Phototherapy for treating pressure ulcers

  • Review
  • Intervention

Authors

  • Chiehfeng Chen,

    Corresponding author
    1. Taipei Medical University - Wan Fang Hospital, Division of Plastic Surgery, Department of Surgery, Tapei, Taiwan
    2. Taipei Medical University, Department of Public Health, School of Medicine, College of Medicine, Taipai, Taiwan
    3. Taipei Medical University, Center for Evidence-Based Medicine, Taipei, Taiwan
    • Chiehfeng Chen, Department of Public Health, School of Medicine, College of Medicine, Taipei Medical University, 250, Wuxing Street, Taipai, 11031, Taiwan. clifchen@tmu.edu.tw.

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  • Wen-Hsuan Hou,

    1. Taipei Medical University, School of Gerontology Health Management, College of Nursing, Taipei, Taiwan
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  • Edwin SY Chan,

    1. Singapore Clinical Research Institute, Epidemiology, Singapore, Singapore
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  • Mei-Ling Yeh,

    1. National Taipei University of Nursing and Health Science, School of Nursing, Taipei, PeiTou, Taiwan
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  • Heng-Lien Daniel Lo

    1. Taipei Medical University, Center for Evidence-Based Medicine, Taipei, Taiwan
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Abstract

Background

A pressure ulcer is defined as "an area of localized injury to the skin and/or underlying tissue, usually over a bony prominence, as a result of pressure, or pressure in combination with shear". The use of phototherapy - that is, light (or laser) used as an adjuvant, non-surgical intervention, with the aim of having a therapeutic effect on healing - has increased recently.

Objectives

To determine the effects of phototherapy on the healing of pressure ulcers.

Search methods

In January 2014, we searched the Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid EMBASE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); and EBSCO CINAHL. We did not restrict the search by language or publication date.

Selection criteria

Randomised controlled trials (RCTs) comparing the effects of phototherapy (in addition to standard treatment) with sham phototherapy (in addition to standard treatment), another type of phototherapy (in addition to standard treatment) or standard or conventional treatment alone.

Data collection and analysis

Two review authors assessed studies for relevance and design according to the selection criteria, extracted data and evaluated study quality. The authors made attempts to obtain missing data by contacting study authors. Disagreement was resolved by consensus and discussion with a third review author.

Main results

We identified seven RCTs involving 403 participants. All the trials were at unclear risk of bias. Trials compared the use of phototherapy with standard care only (six trials) or sham phototherapy (one trial). Only one of the trials included a third arm in which another type of phototherapy was applied. Overall, there was insufficient evidence to determine the relative effects of phototherapy for healing pressure ulcers. Time to complete healing was reported in three studies. Two studies showed the ultraviolet (UV) treated group had a shorter mean time to complete healing than the control group (mean difference -2.13 weeks (95% CI -3.53 to -0.72, P value 0.003)). One study reported that the laser group had a longer mean time to complete healing than the control group (mean difference 5.77 weeks; 95% CI -0.25 to 11.79). However, this result should be interpreted with caution, as these were small studies and the findings may have been due to chance. Three studies reported proportions of ulcers healed with a variety of results. One study reported a different outcome measure, and the other two studies had different treatment durations. These variations did not allow us to pool the studies and draw any conclusions as to whether phototherapy is effective or not. Adverse effects were reported in only two studies that compared phototherapy with control; the risk ratio for adverse events was imprecise. One study reported risk ratio (RR) 0.72 (95%CI 0.18 to 2.80). However, another study reported RR 0.89 (95% CI: 0.71 to 1.12) based on the number of events in each group, rather than the number of people with events. Among five studies reporting the rate of change in ulcer area, three studies found no statistically significant difference between the two groups. Pooling was not undertaken because of differences in outcome measures reported. The results were based on data from trials with unclear risk of bias for which generation of the randomisation sequence, concealment allocation and blinding of outcome assessors were unclear. No studies reported on quality of life, length of hospital stay, pain or cost.

Authors' conclusions

We are very uncertain as to the effects of phototherapy in treating pressure ulcers. The quality of evidence is very low due to the unclear risk of bias and small number of trials available for analysis. The possibility of benefit or harm of this treatment cannot be ruled out. Further research is recommended.

Résumé scientifique

La photothérapie dans le traitement des escarres

Contexte

Les escarres (ulcères de décubitus) sont définies comme des zones de lésions localisées de la peau et des tissus sous-cutanés, habituellement au niveau d'une éminence osseuse, causées par la pression ou par l'association d'une pression et d'un cisaillement. L'utilisation de la photothérapie (exposition à la lumière ou à un laser) comme méthode non chirurgicale adjuvante dans le but d'améliorer la cicatrisation est en augmentation depuis quelque temps.

Objectifs

Évaluer les effets de la photothérapie sur la cicatrisation des escarres.

Stratégie de recherche documentaire

En janvier 2014, nous avons effectué une recherche dans le registre spécialisé du groupe Cochrane sur les plaies, le registre Cochrane des essais contrôlés (CENTRAL), Ovid MEDLINE, Ovid EMBASE, Ovid MEDLINE (In-Process & Other Non-Indexed Citations) et EBSCO CINAHL. La recherche n'a fait l'objet d'aucune restriction par langue ou date de publication.

Critères de sélection

Essais contrôlés randomisés (ECR) comparant les effets de la photothérapie (en plus du traitement standard) avec une photothérapie simulée (en plus du traitement standard), un autre type de photothérapie (en plus du traitement standard) ou un traitement standard ou conventionnel seul.

Recueil et analyse des données

Deux auteurs ont évalué les études en termes de pertinence et de conception selon les critères de sélection, extrait les données et évalué la qualité des études. Les auteurs ont tenté d'obtenir les données manquantes en contactant les auteurs des études en question. Les désaccords ont été résolus par la discussion et, si nécessaire, en consultation avec un troisième auteur de la revue.

Résultats principaux

Nous avons identifié sept ECR portant sur 403 participants. Le risque de biais était incertain dans tous ces essais. Les essais comparaient l'utilisation de la photothérapie avec les soins standard uniquement (six essais) ou les soins standards associés à une photothérapie simulée (un essai). Un seul des essais incluait une troisième branche dans laquelle un autre type de photothérapie a été employé. Dans l'ensemble, il n'y avait pas suffisamment de preuves pour déterminer les effets relatifs de la photothérapie sur la cicatrisation des escarres. Le délai avant cicatrisation complète est rapporté dans trois études. Deux études ont montré que le groupe traité par lumière ultraviolette (UV) avait une durée moyenne de cicatrisation complète plus courte que le groupe témoin (différence moyenne -2,13 semaines (IC à 95 % de -3,53 à -0,72, valeur de P 0,003)). Une étude indique que le groupe traité par laser a eu un temps de cicatrisation complète moyen plus long que le groupe témoin (différence moyenne 5,77 semaines ; IC à 95 % de -0,25 à 11,79). Cependant, ce résultat doit être interprété avec prudence car les études en question sont de petite taille et ce résultat peut être dû au hasard. Trois études ont rapporté les proportions d'escarres cicatrisées, avec des résultats disparates. Une étude rapporte une mesure de résultat différente, et les deux autres études des durées de traitement différentes. Ces différences ne nous permettent pas de regrouper les études et d'en tirer des conclusions quant à savoir si la photothérapie est efficace ou non. Les effets indésirables ont été signalés dans seulement deux études, qui comparaient la photothérapie à un groupe témoin ; le risque relatif d'événements indésirables y est imprécis. Une étude rapporte un risque relatif (RR) de 0,72 (IC à 95 % de 0,18 à 2,80). Cependant, une autre étude rapporte un risque relatif de 0,89 (IC à 95 % de 0,71 à 1,12) sur la base du nombre d'événements dans chaque groupe, plutôt que le nombre de sujets concernés par des événements. Parmi les cinq études rapportant le taux de changement de surface de l'escarre, trois ne trouvent aucune différence statistiquement significative entre les deux groupes. Les résultats des études n'ont pas été regroupés, en raison des différences dans les mesures des résultats rapportés. Les résultats sont basés sur les données d'essais ayant un risque de biais incertain, dans lesquels la génération de la séquence de randomisation, le masquage de la répartition et la mise en aveugle des évaluateurs de résultats n'étaient pas clairs. Aucune des études ne rend compte de la qualité de vie, de la durée des séjours à l'hôpital, de la douleur ni du coût.

Conclusions des auteurs

Nous n'avons donc aucune certitude quant aux effets de la photothérapie sur le traitement des escarres. La qualité des preuves est très faible en raison du clair de biais incertain et du petit nombre d'essais disponibles pour l'analyse. Il n'est pas possible d'exclure la possibilité que ce traitement soit bénéfique ou, au contraire, qu'il puisse être nocif. Des recherches supplémentaires s'imposent.

Notes de traduction

Traduction réalisée par le Centre Cochrane Français

アブストラクト

褥瘡治療のための光線療法

背景

褥瘡は「皮膚および/または下層組織の局所的損傷領域で、通常、骨の隆起部であり、圧迫または圧迫とずれの組み合わせの結果生じる」と定義されている。光線療法――すなわち、光線(またはレーザー)を補助的に手術以外の介入として、治癒に対する治療効果を得ることを目的として用いる――の使用が最近増加している。

目的

褥瘡の治癒に対する光線慮法の効果を検討すること。

検索戦略

2014年1月、Cochrane Wounds Group Specialised Register、Cochrane Central Register of Controlled Trials (CENTRAL)、Ovid MEDLINE、Ovid EMBASE、Ovid MEDLINE (In-Process & Other Non-Indexed Citations)、およびEBSCO CINAHLを検索した。検索には言語または発表日による制限を設けなかった。

選択基準

光線療法(標準治療と併用)の効果を、偽光線療法(標準治療と併用)、別タイプの光線療法(標準治療と併用)、または標準もしくは従来治療単独と比較するランダム化比較試験(RCT)。

データ収集と分析

2名のレビュー著者が、選択基準に従って関連性とデザインに関して研究を評価し、データを抽出し、研究の質を評価した。著者らは、論文の著者に問い合わせ、欠測データの入手を試みた。不一致があれば、合意と第三のレビュー著者との議論により解決した。

主な結果

403人の参加者を対象とした7 件のRCTを同定した。これらの試験はいずれもバイアスのリスクが不明であった。試験では、光線療法使用を標準治療単独(6件)または偽光線療法(1件)と比較していた。これら試験のうち1件のみが別タイプの光線療法を適用する第三の群を設定していた。 全体として、褥瘡治癒のための光線療法の相対的効果を定めるにはエビデンスが不十分であった。完全治癒までの時間は3件の研究で報告されていた。2件の研究では、紫外線(UV)治療群で完全治癒までの平均時間が対照群よりも短いことが示された(平均差-2.13週(95%CI -3.53~-0.72、P値0.003))。1件の研究では、レーザー群で完全治癒までの平均時間が対照群よりも長いことが報告された(平均差5.77週、95%CI-0.25~11.79)。しかし、この結果の解釈には注意が必要である。これらは小規模な研究で、その知見は偶然による可能性があるからである。3件の研究では、治癒した潰瘍の割合が異なるデータにより報告されていた。1件の研究の報告では評価項目が異なり、他の2件では治療期間が異なっていた。このような差異により、研究を統合し、光線療法が有効か否かに関する結論を導き出すことはできなかった。有害作用を報告していたのは光線療法を対照と比べた2件のみで、有害事象のリスク比は不正確であった。1件がリスク比(RR)0.72(95%CI 0.18~2.80)を報告していた。しかし、もう1件では、事象発現者数ではなく、各群における事象件数に基づきRR 0.89(95% CI 0.71 ~1.12)が報告されていた。潰瘍部位における変化の率を報告していた5件のうち、3件では2群間に統計学的有意性は認められなかった。報告された評価項目に差異があったため、統合は行われなかった。この結果は、ランダム割付けの順序生成、割付けの隠蔵化、アウトカム評価者の盲検性が不明でバイアスのリスクが不明な試験からのデータに基づくものであった。いずれの研究でもQOL、入院期間、疼痛、費用に関する報告はなかった。

著者の結論

褥瘡の治療に対する光線療法の効果は非常に不明確である。 バイアスのリスクが不明で、解析に利用できる試験が少数であるため、エビデンスの質は非常に低い。この治療法の利益または害の可能性を除外できない。さらなる研究が推奨される。

訳注

《実施組織》厚生労働省「「統合医療」に係る情報発信等推進事業」(eJIM:http://www.ejim.ncgg.go.jp/)[2016.1.9]
《注意》この日本語訳は、臨床医、疫学研究者などによる翻訳のチェックを受けて公開していますが、訳語の間違いなどお気づきの点がございましたら、eJIM事務局までご連絡ください。なお、2013年6月からコクラン・ライブラリーのNew review, Updated reviewとも日単位で更新されています。eJIMでは最新版の日本語訳を掲載するよう努めておりますが、タイム・ラグが生じている場合もあります。ご利用に際しては、最新版(英語版)の内容をご確認ください。

Plain language summary

Phototherapy for treating pressure ulcers

What are pressure ulcers?

Pressure ulcers (also called bed sores or pressure sores) are sores on the skin caused by constant pressure or friction. They usually affect people who are immobilised or find it difficult to move themselves, for example the elderly or paralysed. Pressure ulcers frequently occur on bony parts of the body, such as the heels and hips, and also on the coccyx (tail bone). Pressure ulcers do not always heal, and, if they do heal, healing can take a long time.

What is phototherapy?

Phototherapy is a treatment in which part of the body is exposed to daylight, a or light of a specific wavelength. It is used for treating a variety of diseases, and may involve lights and lasers. Phototherapy is used to treat pressure ulcers in the hope that it will reduce the time the ulcers take to heal.

The purpose of this review

This review tried to find out whether phototherapy treatment(s) given in addition to standard care (i.e. pressure relief, removal of dead tissue from the wound, infection control and application of dressings) improves healing times for pressure ulcers. Standard care plus phototherapy could be compared against standard care alone, or against standard care plus sham phototherapy, or against standard care plus another type of phototherapy.

Findings of this review

The review authors searched the medical literature up to 7 January 2014, and identified seven relevant medical trials, with a total of 403 participants. Six trials compared the use of phototherapy with standard care only; one trial compared it with standard care plus sham phototherapy. Only one trial included a third treatment group that investigated another type of phototherapy.

Two trials reported the time taken for pressure ulcers to heal completely, and these showed an improvement in healing time for people in the phototherapy group who received treatment with ultraviolet light. However, this result should be interpreted with caution, as these were small, poor quality trials, at unclear risk of bias (i.e. with potentially misleading results), and the findings may have been due to chance. The other trials reported either conflicting results or various measures/time points among trials, which meant that we could not conclude whether or not phototherapy is effective for treating pressure ulcers. Two trials reported incidence of harmful (adverse) effects and noted no significant differences between the phototherapy and standard treatment groups. Four trials provided funding information, two from industry funding, the others from an institutional grant. No studies reported on quality of life, length of hospital stay, pain or cost.

This review identified only a few, small studies provided with insufficient evidence to support the use of phototherapy as a routine treatment for pressure ulcers. More trials will need to be conducted before it can be established whether this treatment works and is safe.

Résumé simplifié

La photothérapie dans le traitement des escarres

Qu'est-ce qu'une escarre ?

Les escarres (également appelées ulcères de décubitus ou plaies de lit) sont des plaies cutanées causées par une pression ou un frottement constants. Elles touchent généralement des sujets immobilisés ou qui ont des difficultés à se déplacer, par exemple les personnes âgées ou paralysées. Les escarres se forment en particulier sur les parties osseuses du corps, tels que les talons et les hanches, et aussi sur le coccyx. La cicatrisation des escarres peut être très longue, et certaines ne cicatrisent pas du tout.

Qu'est-ce que la photothérapie ?

La photothérapie est un traitement qui consiste à exposer une partie de corps à la lumière du jour ou à une lumière d'une longueur d'onde spécifique. Utilisée pour traiter diverses maladies, elle peut faire appel à différents types de lumières et à des lasers. La photothérapie est utilisée pour traiter les escarres dans l'espoir de réduire leur temps de cicatrisation.

Objectif de la revue

La présente revue a essayé de déterminer si les traitements par photothérapie administrés en complément des soins standard (c.-à-d. allégement de la pression, élimination des tissus morts de la plaie, lutte contre l'infection et application de pansements) améliorait le temps de cicatrisation des escarres. Les soins standards associés à la photothérapie pourraient être comparés aux soins standard seule ou aux soins standards avec une photothérapie simulée, ou encore aux soins standards associés à un autre type de photothérapie.

Résultats de la revue

Les auteurs de l'analyse ont effectué une recherche dans la littérature médicale jusqu'au 7 janvier 2014 et identifié sept essais médicaux pertinents, avec un total de 403 participants. Six essais comparaient l'utilisation de la photothérapie avec les soins standard uniquement et un autre les soins standards associés à une photothérapie simulée. Un seul essai incluait un troisième groupe de traitement dans lequel un autre type de photothérapie était étudié.

Deux études rapportent le temps de cicatrisation complète des ulcères ; elles font apparaître une amélioration du temps de cicatrisation pour les sujets du groupe ayant reçu un traitement par photothérapie à la lumière ultraviolette. Cependant, ce résultat doit être interprété avec prudence car il s'agit ici d'essais de mauvaise qualité, portant sur de petits effectifs et comportant un risque de biais mal déterminé (donc donnant des résultats potentiellement trompeurs), et les résultats sont peut-être dus au hasard. Les autres essais ont rapporté soit des résultats contradictoires, soit des mesures ou des points dans le temps différents de l'un à l'autre, de sorte que nous n'avons pas pu conclure si oui ou non la photothérapie était efficace pour le traitement des escarres. Deux études rapportent l'incidence des effets nocifs (indésirables) ; elles n'indiquent aucune différence significative entre les groupes de traitement par photothérapie et par les modalités standard. Quatre essais donnent des informations sur leur financement : deux par l'industrie, les deux autres par une subvention institutionnelle. Aucun des études ne rend compte de la qualité de vie, de la durée des séjours à l'hôpital, de la douleur ni du coût.

Cette revue n'a permis d'identifier que quelques petites études, dont les preuves à l'appui d'une utilisation de la photothérapie dans le traitement de routine des escarres sont insuffisantes. D'autres essais seront nécessaires avant que l'on puisse établir si ce traitement donne des résultats et s'il est sans danger.

Notes de traduction

Traduction réalisée par le Centre Cochrane Français

Laički sažetak

Fototerapija za liječenje dekubitusa

Što su dekubitusi?

Dekubitusi (nazivaju se i tlačni vrijed) su rane na koži prouzročene konstantnim pritiskom ili trenjem. Oni obično nastaju kod ljudi koji su imobilizirani ili se teško pomiču, na primjer kod starijih ili paraliziranih osoba. Dekubitusi se često javljaju na dijelovima tijela gdje se kosti nalaze blizu površine, kao što su pete ili kukovi, kao i na trtici. Dekubitusi se ne zaliječe uvijek, a, ako se i zaliječe, liječenje traje dugo vremena.

Što je fototerapija?

Fototerapija je vrsta liječenja u kojem je dio tijela izložen dnevnom svjetlu, ili svjetlu određene valne duljine. Koristi se za liječenje raznih bolesti, i može uključivati različite svjetiljke i lasere. Fototerapija se koristi u liječenju dekubitusa zbog očekivanja da će smanjiti vrijeme potrebno da se rane zaliječe.

Cilj ovog sustavnog pregleda

Cilj ovog Cochrane sustavnog pregleda bio je analizirati literaturu kako bi se utvrdilo je li terapijafototerapijom dodatno pomaže standardnoj terapiji (tj. smanjenje pritiska, uklanjanje mrtvog tkiva iz rane, kontrola infekcije i upotreba zavoja) u skraćenju vremena potrebnog za cijeljenje dekubitusa. U sustavni pregled uključene su studije u kojima se standardna terapija zajedno s fototerapijom usporedila s isključivo standardnom njegom, ili sa standardnom njegom s lažnom fototerapijom, ili sa standardnom terapijom u kombinaciji s drugim tipom fototerapije.

Rezultati sustavnog pregleda

Autori ovog pregleda pretražili su medicinsku literaturu objavljenu do 7. siječnja 2014. godine i pronašli sedam relevantnih medicinskih ispitivanja, s ukupno 403 sudionika. Šest ispitivanja usporedilo je upotrebu fototerapije sa samom standardnom terapijom; jedno ispitivanje usporedilo je fototerapiju sa standardnom terapijom plus lažnom fototerapijom. Samo jedno ispitivanje uključilo je treći tip liječenja koji istražuje drugačiji tip fototerapije.

Dva ispitivanja prikazala su vrijeme potrebno za potpuno zacjeljenje rana, te su one pokazale napredak u vremenu zacjeljenja kod ljudi u fototerapijskoj skupini koji su primili terapiju ultraljubičastim zrakama. Međutim, taj rezultat bi se trebao uzimati s oprezom, jer su to bile malene studije, niske kvalitete, s nejasnim rizikom pristranosti (npr. moguće je pogrešno navođenje rezultata), i nalazi su mogli biti rezultat slučajnosti. Ostala ispitivanja prikazala su ili suprotstavljene rezultate ili različite vrijednosti mjerenja/vremena između ispitivanja, što znači da iz prikazanih podataka nije moguće zaključiti da li fototerapija ima ili nema učinka u liječenju dekubitusa. Dva istraživanja opisala su pojavu štetnih učinaka (nuspojava), a da pritom nisu zabilježila značajne razlike između fototerapije i skupine pacijenata koja je primala samo standardnu terapiju. Četiri ispitivanja navela su podatke o financiranju studije, od kojih su dva financirana od strane industrije, a ostali su financirani od strane ustanova. Nijedna studija nije izvijestila o kvaliteti života, duljini hospitalizacije, boli ili troškovima.

Ovim Cochrane sustavnim pregledom pronađen je samo malen broj vrlo malih studija koje donose nedovoljan dokaz u korist upotrebe fototerapije u obliku rutinskog liječenja dekubitusa. Potrebno je provesti više istraživanja prije nego bi se moglo utvrditi da li ovakav tip liječenja djeluje i da li je siguran.

Bilješke prijevoda

Hrvatski Cochrane
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அழுத்தப் புண்கள் சிகிச்சைக்கான ஒளிவீச்சு சிகிச்சை

அழுத்தப் புண்கள் என்றால் என்ன?

அழுத்தப் புண்கள் (படுக்கை ரணங்கள் அல்லது அழுத்த ரணங்கள் என்றும் அழைக்கப்படும்) என்பவை தொடர்ந்த அழுத்தம் அல்லது உராய்வின் மூலம் ஏற்படும் காயங்கள் ஆகும். அவை, பொதுவாக அசைவற்று இருப்பவர்கள் அல்லது தாங்களாகவே நகர்வதற்கு சிரமப்படுபவர்கள், உதாரணமாக முதியோர் அல்லது வாதமுடையோர் ஆகியோரை பாதிக்கும். அழுத்தப் புண்கள், பொதுவாக உடலின் எலும்பு பகுதிகளான குதிகால், இடுப்பு, மற்றும் பிட்டம் போன்ற பாகங்களில் ஏற்படும். அழுத்தம் புண்கள் எப்போதும் ஆறுவது இல்லை ,மற்றும் அவைகள் குணமடைந்தாலும், குணமடைவதற்கு நீண்ட காலம் எடுத்து கொள்ளலாம்.

ஒளிவீச்சு சிகிச்சை என்றால் என்ன?

ஒளிக்கதிர் சிகிச்சை என்பது உடல் பகுதியில் பகல்ஒளியை, அல்லது ஒரு குறிப்பிட்ட அலைநீளம் உள்ள ஒளியை படச்செய்வது.. இது பல்வேறு தரப்பட்ட நோய்களின் சிகிச்சையில் பயன்படுத்தப்படுகிறது. மேலும் வெளிச்சம் மற்றும் லேசர் கதிர்களை உள்ளடக்கியது. ஒளிக்கதிர் சிகிச்சையால் புண்கள் ஆற எடுத்துக் கொள்ளும் காலஅளவு குறையும் என்ற நம்பிக்கையில் அழுத்தப் புண்கள் சிகிச்சையில் அது பயன்படுத்தபடுகிகிறது.

திறனாய்வின் நோக்கம்

இந்த ஆய்வு வழக்கமான சிகிச்சைமுறையுடன் ஒளிக்கதிர் சிகிச்சை (கள்) கூடுதலாக கொடுக்கப்படும் போது (அதாவது அழுத்த நிவாரணம், காயத்திலிருந்து இறந்த திசு அகற்றுதல், தொற்று நோய் கட்டுப்பாடு மற்றும் காயத்திற்கு கட்டுபோடுதல் ) அழுத்த புண்கள் குணமடைவதற்கான காலஅளவை குறைக்கிறதா என்பதை கண்டுபிடிக்க முயற்சி செய்தது. வழக்கமான சிகிச்சை முறையுடன் ஒளிக்கதிர் சிகிச்சை கொடுப்பதை, வழக்கமான சிகிச்சை மட்டும் கொடுப்பதுடனோ அல்லது வழக்கமான சிகிச்சை முறையுடன் ஒரு போலி ஒளிக்கதிர் சிகிச்சை கொடுப்பதுடனோ அல்லது வழக்கமான சிகிச்சை முறையுடன் மற்றொரு வகை ஒளிக்கதிர் சிகிச்சை கொடுப்பதுடனோ ஒப்பிடலாம்.

இந்த திறனாய்வின் கண்டுப்பிடிப்புகள்

இந்த ஆய்வின் ஆசிரியர்கள் 2014 ஜனவரி7 தேதி வரையிலான மருத்துவ இலக்கியத்தை தேடி மொத்தம் 403 பங்கேற்பாளர்களை கொண்ட 7 ஆய்வுகளை கண்டறிந்தார்கள் . ஆறு சோதனைகள் ஒளிக்கதிர் சிகிச்சையை வழக்கமான சிகிச்சையுடன் பயன்படுத்துவதை வழக்கமான சிகிச்சை மட்டுமே கொடுப்பதுடன் ஒப்பிட்டுள்ளது ; ஒரு சோதனை வழக்கமான சிகிச்சையுடன் ஒரு போலித் ஒளிக்கதிர் சிகிச்சை கொடுப்பதுடன் ஒப்பிட்டுள்ளது.. ஒரே ஒரு ஆய்வு மட்டும் மூன்றாம் சிகிச்சை குழு கொண்டு வேறுவகையான ஒளிக்கதிர்சிகிச்சையை ஆராய்ந்துள்ளது.

இரண்டு சோதனைகள் அழுத்த புண்கள் முற்றிலும் ஆற எடுத்துக்கொள்ளும் காலஅளவின் தகவல்களை தந்தன , மற்றும் இந்த சோதனைகள் புற ஊதா ஒளி சிகிச்சை பெற்ற ஒளிக்கதிர் குழுவில் உள்ள பங்கேற்பாளர்களின் அழுத்த புண்கள் குணமடையும் காலஅளவில் ஒரு மேம்பாட்டை காண்பித்தது. எனினும், இந்தமுடிவு கவனத்தோடு விளக்கப்படவேண்டிய ஒன்று. ஏனெனில் இவை சிறிய, குறைந்த தர சோதனைகளில் இருந்து வந்தவை .மேலும் ஒருநிலைசார்பு பற்றிய தெளிவின்மையும் உள்ளது (அதாவது தவறான முடிவுகளை எடுக்க சாத்தியம் கொண்டவை) மற்றும் கண்டுபிடிப்புகள் சந்தர்ப்பம் காரணமாக இருந்திருக்கலாம். மற்ற பரிசோதனைகள், முரண்பட்ட முடிவுகளை குறிப்பிட்டன அல்லது சோதனைகளின் மத்தியில் பல்வேறுபட்ட நடவடிக்கைகள் / நேரம் புள்ளிகள் என்ற தகவல்களை குறிப்பிட்டதால் எங்களால் ஒளிக்கதிர் சிகிச்சை அழுத்தப் புண்களை ஆற்றுவதில் பயனுள்ளதாக இல்லையா என்பதை முடிவு செய்யமுடியவில்லை. இரண்டு சோதனைகள் பாதகமான விளைவுகளின் நிகழ்வை தெரிவித்தன மேலும் ஒளிக்கதிர் மற்றும் தரமான சிகிச்சை குழுக்களுக்கு இடையே குறிப்பிடத்தக்க வேறுபாடுகள் இல்லை என குறிப்பிட்டன. நான்கு சோதனைகள் நிதியுதவி தகவல்களை வழங்கியுள்ளன.bஇரண்டு தொழில் நிதியில் இருந்தும், மற்றவை ஒரு நிறுவன மானியத்தில் இருந்தும் நிதிஉதவி பெறப்பட்டதாக தகவல்களை தந்தன. வாழ்க்கை தரம் , மருத்துவமனையில் தங்கும் காலம், வலி ​​அல்லது செலவு ஆகியவற்றை பற்றிய தகவல்களை ஆய்வுகள் எதுவும் தெரிவிக்கவில்லை.

இந்த ஆய்வு அழுத்தப் புண்களுக்கு ஒரு வழக்கமான சிகிச்சையாக ஒளிக்கதிர் சிகிச்சை பயன்படுத்துவதற்கு ஆதரவாக மிகக்குறைவான சான்றுகளை கொடுத்த ஒரு சில, சிறிய ஆய்வுளையே அடையாளம் கண்டது. இந்த சிகிச்சை பயனுள்ளதா மற்றும் பாதுகாப்பானதா என்பதை முடிவு செய்யுமுன் மேலும் அதிக சோதனைகள் நடத்தப்பட வேண்டும்.

மொழிபெயர்ப்பு குறிப்புகள்

மொழிபெயர்ப்பு: க. அழகுமூர்த்தி மற்றும் சி.இ.ப.ஏன்.அர். குழு

平易な要約

褥瘡治療のための光線療法

褥瘡とは何か?

褥瘡(床ずれまたは圧迫潰瘍とも呼ばれる)は、常に圧迫または摩擦を受けることが原因で皮膚に生じる潰瘍である。例えば高齢者や麻痺のある人のように動けない、あるいは自身で動くのが困難な人が、通常、冒される。褥瘡は、かかとおよび股関節部、また尾骨(尾てい骨)などの身体の骨ばった部分に生じることが多い。褥瘡は、必ずしも治癒するとは限らず、治癒する場合でも長期間かかる。

光線療法とは何か?

光線療法は、身体の一部を日光または特定の波長の光線にさらす治療法である。さまざまな疾患の治療に使用され、光線およびレーザーを用いる場合がある。光線療法は、潰瘍の治癒までにかかる時間が短縮すると期待されて褥瘡の治療に用いられている。

このレビューの目的

本レビューでは、標準治療(圧迫軽減、創傷から壊死組織を除去、感染制御、包帯の使用)に加えて光線療法を施すことで、褥瘡の治癒期間が改善するかどうかを見出そうと試みた。標準治療と光線療法の併用は、標準治療単独、標準治療と偽光線療法の併用、標準治療と別タイプの光線療法の併用との比較が考えられた。

このレビューの調査結果

レビュー著者は、2014年1月7日までの医学文献を検索し、関連性のある7件の臨床試験(参加者403人)を同定した。光線療法の使用を標準治療単独と比べた試験が6件、標準治療および偽光線療法の併用と比べた試験が1件であった。1件のみが別タイプの光線療法を検討する第三の群を設定していた。

2件の試験では、褥瘡が完全に治癒するまでにかかる時間が報告され、紫外線による治療を受けた光線療法群の患者の治癒時間が改善を示した。しかし、この結果の解釈には注意が必要である。これらの試験は小規模で、質が不良の試験であり、バイアスのリスク(すなわち、誤解を招きかねない結果を伴う)が不明で、この知見は偶然による可能性があるからである。他の試験では、矛盾する結果が報告されたり、評価項目/時点が試験により異なっていたため、光線療法が褥瘡の治療に有効であるかどうかに関して結論を得ることができなかった。2件の試験では、害になる(有害な)作用が報告され、光線療法と標準治療群とで有意差はみられなかった。4件の試験では資金情報が明らかにされ、2件は産業界からの資金、他の2件は研究施設からの助成金を得ていた。いずれの研究でもQOL、入院期間、疼痛、費用に関する報告はなかった。

本レビューで同定した少数の小規模な研究では、光線療法を褥瘡のルーチン治療として使用することを支持するにはエビデンスが不十分であった。この治療の有効性と安全性を確立するまでには、さらに多くの試験を実施する必要がある。

訳注

《実施組織》厚生労働省「「統合医療」に係る情報発信等推進事業」(eJIM:http://www.ejim.ncgg.go.jp/)[2016.1.9]
《注意》この日本語訳は、臨床医、疫学研究者などによる翻訳のチェックを受けて公開していますが、訳語の間違いなどお気づきの点がございましたら、eJIM事務局までご連絡ください。なお、2013年6月からコクラン・ライブラリーのNew review, Updated reviewとも日単位で更新されています。eJIMでは最新版の日本語訳を掲載するよう努めておりますが、タイム・ラグが生じている場合もあります。ご利用に際しては、最新版(英語版)の内容をご確認ください。

Laienverständliche Zusammenfassung

Phototherapie zur Behandlung von Druckgeschwüren (Dekubiti)

Was sind Druckgeschwüre?

Druckgeschwüre (auch Wundliegegeschwüre, Dekubitusgeschwüre oder Dekubiti genannt) sind Schädigungen der Haut durch dauerhaften Druck oder Reibung. Gewöhnlich sind davon Menschen betroffen, die nicht selbst mobil sind oder sich nur schwer bewegen können, z.B. ältere oder gelähmte Menschen. Druckgeschwüre treten häufig an knochigen Körperstellen wie beispielsweise Fersen und Hüften, aber auch am Steißbein auf. Druckgeschwüre verheilen nicht immer, und wenn doch, so kann der Heilungsprozess sehr lange dauern.

Was ist Phototherapie?

Bei der Behandlung mittels Phototherapie wird ein Teil des Körpers dem Tageslicht oder einem Licht bestimmter Wellenlänge ausgesetzt. Diese Therapie wird bei einer Vielfalt von Krankheiten verwendet. Dabei können Licht und Laser zum Einsatz gelangen. Phototherapie wird zur Behandlung von Druckgeschwüren in der Hoffnung eingesetzt, dass die Heilungsdauer dadurch verkürzt werden kann.

Zielsetzung dieses Reviews

In diesem Review sollte herausgefunden werden, ob die zusätzliche Behandlung mit Phototherapie(n) neben der üblichen Versorgung (d.h. Entlastung, Entfernung toten Gewebes von der Wunde, Entzündungsprophylaxe und -bekämpfung und Wundverbände) die Heilungszeit bei Druckgeschwüren verkürzt. Eine Kombination aus Standardtherapie und Phototherapie könnte verglichen werden mit einer Standardtherapie allein, oder mit einer Standardtherapie plus simulierter Phototherapie, oder mit einer Standardtherapie plus einer weiteren Form von Phototherapie.

Ergebnisse dieses Reviews

Die Autoren des Reviews recherchierten medizinische Fachliteratur bis zum 7. Januar 2014, und fanden sieben stichhaltige medizinische Studien mit insgesamt 403 teilnehmenden Personen. Sechs Studien verglichen den Einsatz von Phototherapie mit der Behandlung nach Standardtherapie allein; eine Studie verglich die Phototherapie mit einer Kombination aus Standardtherapie und fingierter Phototherapie. Nur eine Studie bezog eine dritte Behandlungsgruppe mit ein, bei der die Wirkung einer anderen Art von Phototherapie untersucht wurde.

In zwei Studien wurde die Zeit bis zum vollständigen Abheilen der Druckgeschwüre erfasst. Daraus ergab sich eine Verbesserung der Heilungszeit bei Patienten in der Studiengruppe mit Phototherapiebehandlung, die mit UV-Licht behandelt wurden. Dieses Ergebnis sollte jedoch mit Vorbehalt betrachtet werden, da es sich hierbei um kleine Studien von geringer Qualität mit unklarem Bias-Risiko (d.h. möglicherweise irreführenden Ergebnissen) handelte, und die Erkenntnisse auch zufälliger Art sein könnten. Die anderen Studien kamen entweder zu widersprüchlichen Ergebnissen oder unterschiedlichen Messungen/Zeiten innerhalb der Studien, was bedeutet, dass wir keine Schlussfolgerungen hinsichtlich der Frage ziehen konnten, ob Phototherapie zur Behandlung von Druckgeschwüren wirksam ist oder nicht. In zwei Studien wurde vom Auftreten unerwünschter Nebenwirkungen berichtet. In diesen Studien konnten keine signifikanten Unterschiede zwischen der Phototherapie-Gruppe und der Gruppe mit Standardbehandlung festgestellt werden. Vier Studien gaben Informationen zur Finanzierung an. Zwei davon wurden von der Industrie finanziert, die anderen aus institutionellen Fördergeldern. Keine der Studien machte Angaben zur Lebensqualität, zur Verweildauer im Krankenhaus, zu Schmerzen oder Kosten.

Zu diesem Review konnten nur wenige kleine Studien gefunden werden, deren Evidenz nicht ausreicht, um den Einsatz von Phototherapie als Routinebehandlung bei Druckgeschwüren zu empfehlen. Es müssen erst noch mehr Studien durchgeführt werden, bevor abschließend festgestellt werden kann, ob diese Behandlungsmethode wirksam und sicher ist.

Anmerkungen zur Übersetzung

B. Bayerlein, freigegeben durch Cochrane Schweiz.

Summary of findings(Explanation)

Summary of findings for the main comparison. Phototherapy versus control for treating pressure ulcers
  1. 1 According to risk of bias analysis table, there is a concern about bias in this study.
    2 The interventions used in the studies were diverse, as were the participant groups, and stages of wounds.
    3 The results show both potential harm and benefit from the intervention, the low number of participants included in the studies and available for analysis should be noted along with the width of the confidence intervals.

Phototherapy versus control for treating pressure ulcers
Patient or population: patients being treated for pressure ulcers
Settings: hospitals, nursing homes, outpatient settings
Intervention: phototherapy versus control
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Control Phototherapy versus control
Time to complete healing (weeks) (UV vs control)
Scale from: 0 to complete healing
The mean time to complete healing (weeks) (UV vs control) in the control groups was
7.95 weeks
The mean time to complete healing (weeks) (UV vs control) in the phototherapy groups was
2.13 lower
(3.53 to 0.72 lower)
 32
(2 studies)
⊕⊝⊝⊝
very low 1,2,3
 
Time to complete healing (weeks) (laser vs control)
weeks. Scale from: 0 to complete healing.
The mean time to complete healing (weeks) (laser vs control) in the control groups was
6.83 weeks
The mean time to complete healing (weeks) (laser vs control) in the intervention groups was
5.77 higher
(0.25 lower to 11.79 higher)
 8
(1 study)
⊕⊝⊝⊝
very low 1,2,3
 
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI)
CI: confidence interval
GRADE Working Group grades of evidence
High quality: further research is very unlikely to change our confidence in the estimate of effect
Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate
Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate
Very low quality: we are very uncertain about the estimate

Background

Description of the condition

According to the European Pressure Ulcer Advisory Panel (EPUAP) and the National Pressure Ulcer Advisory Panel (NPUAP), a pressure ulcer is defined as "an area of localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in combination with shear" (EPUAP-NPUAP 2009). The stages of pressure damage and ulceration have been characterised as follows:

  • Stage 1: non-blanchable area of redness without epithelial loss;

  • Stage 2: ulcer presents either as an intact, or ruptured, serum-filled blister, or as a partial loss of dermal tissue;

  • Stage 3: full-thickness dermal loss not exposing muscle, tendon or bone;

  • Stage 4: ulcer has extensive tissue loss sufficient to expose muscle, tendon or bone (EPUAP-NPUAP 2009).

Pressure ulcers occur most commonly on the hips, buttocks and heels of the elderly and immobile (Kroger 2009).

A national survey of pressure ulcers in the USA reported a prevalence of 14.8% across 365 acute hospitals (Amlung 2001). Another review of hospitals showed large variations in reported prevalences that ranged from 5.1% to 32.1% in the UK, and from 4.7% to 29.7% in the USA and Canada (Kaltenthaler 2001). A later epidemiological study in Europe, Canada and the USA described the reported prevalence of pressure ulcers in European hospitals as ranging from 8.3% to 23% (Vanderwee 2007). In the UK, the overall prevalence of pressure ulcers within care settings was 10.2%, with 59% of these being hospital-acquired pressure ulcers (Phillips 2009). Pressure ulcers result in delayed recovery, and can increase the duration of hospital stay, leading to higher treatment costs and an impaired quality of life. In the USA 1.7 million people annually develop a pressure ulcer, and their treatment was estimated to have cost USD 6.4 billion in 1994 and USD 8.5 billion in 1997 (Allman 1997). The cost increased to USD 11 billion in 2006 (Russo 2008). The costs of pressure ulcer treatment (prevention) for England were estimated as high as £755 million (West 1994). The daily cost of treating a pressure ulcer varies from £1,064 to £10,551, which resulted in the total cost in the UK is £1.4–£2.1 billion annually (Bennett 2004). The estimated cost of treating a pressure ulcer case increased from £1,214 to £ 14,108 in a later study (Dealey 2012).
A Dutch study found that costs associated with the care of pressure ulcers were the third highest after those for cancer and cardiovascular diseases (Health Council of the Netherlands 1999).

Description of the intervention

Phototherapy consists of exposure to daylight, or a specific wavelength of light; it is used for treating a variety of diseases. The use of light (or laser) as an adjuvant  (additional) non-surgical intervention with the aim of helping healing has increased in recent times (Whinfield 2009). There are several terms that refer to light therapy, for example; phototherapy, low level laser therapy (LLLT), low power laser therapy (LPLT), low intensity laser therapy (LILT), cold laser, therapeutic laser, light emitting diode (LED), low reactive level laser, diode laser (Enwemeka 2005), and UV light.

Phototherapy regimens are potentially very diverse and involve numerous treatment variables such as:

Phototherapy can be used to treat a variety of medical conditions and is thought to: reduce the swelling and inflammation associated with acute injuries in superficial muscles or tendons; improve wound healing of slow-to-heal or non-healing wounds in soft tissues or tendons; enhance absorption of interstitial fluid (fluid outside cells) and increase lymphatic circulation and drainage to increase tissue regeneration (Hawkins 2007).

Pressure ulcers are treated using a multiple-intervention approach. Phototherapy is usually an adjuvant intervention used alongside standard pressure ulcer care. Standard care may vary depending on the setting and local practice, but will typically consist of the following elements: pressure relief, debridement (removal of dead tissue), infection control and wound dressing. Although in vivo studies have shown a positive effect of phototherapy on wound healing, its mode of action is still not completely understood (Coombe 2001; Smith 1991).

Some phototherapy-related adverse events have been reported, for example erythema (photo-toxic/photo-allergic redness), pruritus (itching), and reactivation of viral infection (e.g. herpes simplex virus). Some chronic adverse effects, such as photo-ageing or skin cancer, have also been reported (Laube 2001). However, overall, the rate of acute adverse events, and in particular the rate of severe adverse events, has been reported as being low (Martin 2007).

How the intervention might work

The treatment goals of phototherapy are to eradicate bacteria from the ulcer, remove slough (loose, dead tissue) (Burger 1985), and stimulate the growth of granulation tissue and epidermis (Freytes 1965). It has been suggested that phototherapy could accelerate wound healing through various mechanisms such as: acceleration of the inflammatory phase (Robinson 1994); enhancing prostaglandin secretion (Eaglstein 1975; Kert 1989); enhancing collagen synthesis (Karu 1989; Monstrey 2002); enhancing fibroblast division (Karu 1989); epithelisation of tissue (Herascu 2005); proliferation of various cells (AlGhamdi 2012); enhancing macrophage phagocytosis (Rochkind 1989); activation of the immune system (Enwemeka 1988); enhancing blood flow and vascular permeability (Greaves 1970; Horwitz 1999; Ramsay 1976); inactivating bacteria (High 1983); stimulating keratinocyte division and motility (Grossman 1998; Haas 1990); and enhancing adenosine-5'-triphosphate (ATP) synthesis (Karu 1995). ATP transports chemical energy within the cells for metabolism. Light (phototherapy) increases ATP synthesis and proton gradients, which lead to an increase in cellular activity. Moreover, phototherapy has been shown to stimulate the expression of multiple genes related to cellular migration, proliferation, and also to modulate the production of growth factors and cytokines (Peplow 2011; Zhang 2003).

Why it is important to do this review

Phototherapy, including low-level laser therapy (LLLT), has been proposed as a promising treatment option for open wounds. Mester was the first to document the biological effects of LLLT in case reports (Mester 1971). There are also sparse references in the recent literature to the use by physical therapists of ultraviolet (UV) light for wound healing. The existing literature concentrates on broad-spectrum UV light sources (Burger 1985; Freytes 1965). Since Wills 1983 published the first randomised controlled trial (RCT) on this topic, several RCTs have made further investigations (Dehlin 2003; Durović 2008; Lucas 2003; Nussbaum 1994; Schubert 2001; Shojaei 2008). This is a timely opportunity to undertake a systematic review that summarises the existing evidence in order to inform practice, and identifies gaps in the research evidence to guide future research.

Objectives

To determine the effects of phototherapy on the healing of pressure ulcers.

Methods

Criteria for considering studies for this review

Types of studies

We included randomised controlled trials (RCTs) evaluating phototherapy in the treatment of pressure ulcers. Quasi-randomised trials or controlled clinical trials (CCTs) were not considered in this review.

Types of participants

People of any age with pressure ulcers of any stage in any care setting. Participants were the primary unit of analysis. We did not include studies that analysed per ulcer because of the potential interaction between ulcers in a patient.

Types of interventions

The primary intervention was any form of single or multi-wavelength phototherapy in combination with usual pressure ulcer management. Our review includes low level laser therapy (LLLT), low power laser therapy (LPLT), low intensity laser therapy (LILT), cold laser, therapeutic laser, light emitting diode (LED), low reactive level laser, diode laser (Enwemeka 2005), and UV light.

Acceptable control interventions included no phototherapy (usual care alone), sham phototherapy (an inactivated light source (with standard care)), or another form of phototherapy (with standard care) that is distinct from the primary intervention.

Types of outcome measures

Primary outcomes

Wound healing as measured by:

  • time to healing/rate of healing;

  • number of wounds healed in a specified time period.

Adverse events.

Secondary outcomes
  • Change in wound size or wound surface area.

  • Quality of life.

  • Length of hospital stay.

  • Pain (as measured by a validated scale).

  • Cost.

Search methods for identification of studies

Electronic searches

For this seventh update we searched the following databases to identify reports of relevant randomised clinical trials:

  • The Cochrane Wounds Group Specialised Register (searched 7 January 2014);

  • The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 12);

  • Ovid MEDLINE (1948 to November Week 3 2013);

  • Ovid EMBASE (1980 to 2014 Week 01);

  • Ovid MEDLINE (In-Process & Other Non-Indexed Citations 7 January 2014); and

  • EBSCO CINAHL (1982 to 7 January 2014).

We used the following search strategy in the Cochrane Central Register of Controlled Trials (CENTRAL):

#1 MeSH descriptor Pressure Ulcer explode all trees
#2 pressure NEXT (ulcer* or sore*):ti,ab,kw
#3 decubitus NEXT (ulcer* or sore*):ti,ab,kw
#4 (bed NEXT sore*) or bedsore:ti,ab,kw
#5 chronic NEXT ulcer*: ti,ab,kw
#6 (#1 OR #2 OR #3 OR #4 OR #5)
#7 MeSH descriptor Phototherapy explode all trees
#8 MeSH descriptor Laser Therapy explode all trees
#9 (phototherap* or "photoradiation therapy" or "photon therapy" or
"light therapy"):ti,ab,kw
#10 pulse* NEAR/3 light:ti,ab,kw
#11 pulse NEAR/3 (monochromic or monochromatic):ti,ab,kw
#12 light NEAR/3 monochromatic:ti,ab,kw
#13 wavelength NEAR/3 light:ti,ab,kw
#14 polarized NEAR/3 light:ti,ab,kw
#15 non-polarized NEAR/3 light:ti,ab,kw
#16 ("laser therapy" or LLLT or LPLT or LILT or (cold NEXT laser*) or
(therapeutic NEXT laser*) or (light NEXT emitting NEXT diode*) or LED or
(low NEXT reactive NEXT level NEXT laser*) or (diode NEXT laser*)):ti,ab,kw
#17 (#7 OR #8 OR #9 OR #10 OR #11 OR #12 OR #13 OR #14 OR #15 OR #16)
#18 (#6 AND #17)

We adapted this strategy to search Ovid MEDLINE, Ovid EMBASE and EBSCO CINAHL and these can be found in Appendix 1, Appendix 2 and Appendix 3 respectively. The Ovid MEDLINE search was combined with the Cochrane Highly Sensitive Search Strategy for identifying randomised trials in MEDLINE: sensitivity- and precision-maximizing version (2008 revision) (Lefebvre 2011). The EMBASE and CINAHL searches were combined with the trial filters developed by the Scottish Intercollegiate Guidelines Network (SIGN 2011). There were no restrictions on the basis of date or language of publication.

We also searched the following ongoing trials databases using keywords including phototherapy and pressure ulcers

  • EU Clinical Trials Register (https://www.clinicaltrialsregister.eu/index.html)

  • ClinicalTrials.gov (http://www.clinicaltrials.gov/)

  • WHO International Clinical Trials Registry Platform (ICTRP) (http://www.who.int/ictrp/en/)

Searching other resources

We searched the bibliographies of all articles retrieved for reports of any potentially relevant trials. We contacted the authors of included studies and asked for unpublished trial reports. One author (CC) contacted the suppliers of two phototherapy devices (Glorious Union Medtech Corp and Sure Care Products Co Ltd) to request information about additional studies. The relevant device information and intervention regimes were described clearly and confirmed via manufacturers' websites and handbooks.

Data collection and analysis

Selection of studies

Two review authors assessed the titles and abstracts identified for study relevance and design, according to the selection criteria. We obtained full-text articles of any reports that potentially satisfied the inclusion criteria. Two review authors checked these full papers for eligibility. Any disagreement was resolved by consensus and, if necessary, by referral to a third review author.

Data extraction and management

We extracted and summarised details of studies using a standardised data extraction sheet. We contacted the trial authors to request missing information for those studies that had been reported with data missing. We also contacted manufacturers of phototherapy devices to obtain additional information. When studies had been published more than once, we extracted data from all the reports, and nominated one as the primary reference. Two review authors extracted data independently. We extracted the following data:

  • author; title; source of reference;

  • country and publication year of study;

  • setting of study (e.g. primary care);

  • number and description of participants;

  • intervention and comparison;

  • co-interventions;

  • treatment regimen (wavelength, duration, frequency, energy etc.);

  • who delivered the treatment;

  • outcomes and method of measurement;

  • duration of follow-up;

  • evaluation of cost, adverse events, pain data, quality of life data, length of hospital stay.

Assessment of risk of bias in included studies

Two review authors independently assessed each included study using the Cochrane Collaboration tool for assessing risk of bias (Higgins 2011). This tool addressed specific domains, namely random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, selective reporting and other bias (e.g. extreme baseline imbalance) (see Appendix 4 for details of criteria on which the judgments were based). Blinding and completeness of outcome data for each outcome were assessed separately. We completed a 'Risk of bias' table for each eligible study. Any disagreement between the two review authors was discussed to achieve a consensus.

The assessments of risk of bias were presented in summary figure to illustrate all of the judgments in a cross-tabulation of studies. This display of internal validity indicates the weight the reader may give to the results of each study. Discrepancies were resolved through discussion with all review authors. We also appraised the quality of evidence by using the GRADE approach in relation to study limitations, inconsistency of results, indirectness, imprecision and risk of bias, as specified in the Handbook (Higgins 2011) and presented in the Summary of findings table.

Measures of treatment effect

We analysed data using RevMan 5.2 (RevMan 2011). We used risk ratio (RR) with 95% confidence interval (CI) as the effect measure for dichotomous outcomes. For continuous outcomes, we used the mean difference (MD), or, when the scale of measurement used differed across trials, the standardised mean difference (SMD [Hedge'sg]). For time-to-event outcomes (e.g. time to healing), we used the hazard ratio (HR) with 95% CI. 

Unit of analysis issues

Participants in the control and intervention groups were the primary unit of analysis. We did not include studies that analysed per ulcer because of the potential interaction between ulcers in a patient.

Dealing with missing data

We contacted trial authors for missing data. Sensitivity analyses were performed to assess how sensitive results are to reasonable changes in the assumptions that are made. For those trials with incomplete outcome data we followed the guidance in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).

Assessment of heterogeneity

We assessed clinical studies qualitatively, and assessed design heterogeneity on the basis of the participant, intervention, control, outcome and design elements listed in the 'Characteristics of included studies' table. We assessed statistical heterogeneity using the I2 statistic (Higgins 2003).

Data synthesis

We synthesised data using Cochrane RevMan 5.2 software (RevMan 2011). Data synthesis depended on the quality, design and heterogeneity of the included trials. A meta-analysis was not performed if the clinical characteristics, methodology, or outcome measures were too diverse. All results were presented with 95% CIs. If data were inappropriate for pooling or analysis, for example, when there was high heterogeneity between interventions (types and regimes), or variation between populations or in stages of wounds, the results were presented narratively with discussion and agreed by reviewers.

Subgroup analysis and investigation of heterogeneity

If the included studies investigated similar populations and used similar variable and outcome definitions etc., we applied the fixed-effect model for meta-analysis. When the studies had high heterogeneity, we used the random-effects model for analysis, and explored the possible reasons behind the heterogeneity by performing further subgroup analysis. We performed subgroup analyses, when appropriate, to assess the impact of the grade of ulcer, study quality, type of intervention, participants and setting on the outcome, although we recognised that this would only be possible for trials that recruited and allocated participants on the basis of the grade of the ulcer.

Results

Description of studies

Results of the search

See: Characteristics of included studies; and Characteristics of excluded studies.

The initial search identified 131 titles after we had removed duplicates. Independent review of the abstracts by two review authors (CC, HWH) identified 15 articles that potentially met the inclusion criteria, or contained useful references, and we retrieved full text articles of these. Two review authors independently assessed the papers according to the inclusion and exclusion criteria.

There was complete agreement between the review authors, and seven papers, involving a total of 403 people, were included (Dehlin 2003; Durović 2008; Lucas 2003; Nussbaum 1994; Schubert 2001; Shojaei 2008; Wills 1983) (see Characteristics of included studies). The Characteristics of excluded studies table summarises details of the six studies that did not meet the inclusion criteria and were subsequently excluded from the review (Dolan 1989; Iordanou 2002; Mol 1994; Nussbaum 2013; Onigbinde 2010; Taly 2004). We are currently waiting for responses from the authors of two studies (Dehlin 2007; Lucas 2000), to clarify some information, and so these studies are currently classified as studies awaiting classification (Figure 1).

Figure 1.

Study flow diagram.

Included studies

A summary of characteristics of the included studies is presented in the table of Characteristics of included studies. Seven studies are included in this review; one three-arm study (Nussbaum 1994), and six two-arm studies (Dehlin 2003; Durović 2008; Lucas 2003; Schubert 2001; Shojaei 2008; Wills 1983). These studies were set in hospitals, nursing homes and outpatient settings. Trial sizes ranged from 16 to 198 participants. The seven studies were conducted from 1983 to 2008, included six different interventions (UVC, US, LLLT, Pulsed monochromatic light, polarized light therapy, diode laser). Four studies were conducted from Europe, two from North America and one from Asia.

Excluded studies

We excluded six studies. Two studies were not RCTs (Mol 1994; Onigbinde 2010). Two studies had applied the intervention and conventional treatments to individual participants, and ulcers were the unit of randomisation, and we were concerned that it might be difficult to separate any systemic effects when both treatments were applied to the same person (Iordanou 2002; Taly 2004). One study was excluded because the outcomes were reported for ulcers rather than participants, which violated our study protocol (Nussbaum 2013). Dolan 1989 had problems with randomisation and participants did not necessarily receive the intervention to which they had been allocated. See: Characteristics of excluded studies.

Risk of bias in included studies

The risk of bias in the included studies is summarised in Figure 2 and Figure 3.

Figure 2.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study

Figure 3.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies

Allocation

Generation of the randomisation sequence

Although all included studies stated that the participants were randomly allocated, only Durović 2008 reported the method used to generate the random sequence. Lucas 2003 used a centralised computerised telephone service, which could be considered to be a computer-generated sequence.

Allocation concealment

Most studies did not provide information about allocation concealment. They described the allocation to treatment groups as 'randomised' but provided no further description about how randomisation was achieved. Only Lucas 2003 mentioned that a central computerised telephone service was used for allocation, which could be considered to be low risk of selection bias .

Blinding

Blinding participants

One study provided a sham intervention as the control treatment (Dehlin 2003). In Wills 1983, mica was provided to cover the wound and provide blinding. However, blinding of participants might be difficult when the intervention is visually, or physically, obvious.

Blinding the person delivering the intervention

Outcomes may be influenced when trial-related personnel are aware of the group to which participants have been randomised. No study provided details about how they avoided performance bias.

Blinding the outcome assessors

All but two studies stated that outcome assessors were blinded (Schubert 2001; Shojaei 2008).

Incomplete outcome data

One study conducted intention-to-treat analysis, as there were no reported withdrawals (Shojaei 2008). Dehlin 2003 reported per-protocol analysis; 34 of the original 198 participants dropped out, mainly due to protocol violation, and were not included in the final analysis. Durović 2008 reported per-protocol analysis; eight of the original 48 patients dropped out for different reasons. Lucas 2003 reported analysis based on intention-to-treat; six out of the original 86 participants dropped out and no further explanation was provided. In Nussbaum 1994, four of the original 20 patients did not complete the study due to medical complications or transfer to surgical treatment. In Schubert 2001, 13 out of the original 72 patients did not complete the study. Wills 1983 lost two of the 18 participants recruited: one participant died and another was transferred to an acute care hospital; neither was included in the data analysis. In general, except Dehlin 2003 study with unclear loss follow up reporting, the loss of follow up in both groups were balanced.

Selective reporting

Most studies presented data for outcomes listed in the methods sections of trial reports. In Dehlin 2003, however, outcomes mentioned in the methods section, such as almost complete healing (<10% remaining ulcer area) and time to partial healing (<50% remaining ulcer area) were not reported comprehensively. In Wills 1983, there was not sufficient information provided to permit a judgment to be made about selective reporting bias.

Other potential sources of bias

Data about baseline comparability for prognostic factors were worse in the control group in Durović 2008, which may have tended to favour the treatment effect.

Overall, the included studies were judged as being at unclear risk of bias and the majority of studies were unblinded.

Effects of interventions

See: Summary of findings for the main comparison Phototherapy versus control for treating pressure ulcers

Primary outcome measure

Time to complete healing

Two studies reported time to complete healing (Nussbaum 1994; Wills 1983), and a third the proportion of ulcers healed within specified time periods (Schubert 2001). In the Wills 1983 study, mean time to complete healing was 6.3 weeks in the UV treated group, significantly less than the mean of 8.4 weeks in the placebo group (P value < 0.02). Nussbaum 1994 provided information about time to complete healing (in weeks) in figures presented in the trial report. These data were on a per wound basis, with two participants having two ulcers. We defined the time to complete healing for these two participants as being the time by which both ulcers had completely healed. With results calculated individually in this manner, the time to complete healing was 4.6 weeks (n = 5 participants, SD 1.14) for the group that received ultrasound (US) and UV treatment; 12.6 weeks (n = 5 participants, SD 5.50) for the laser group; and 6.83 weeks (n = 6 participants, SD 3.19) for the control group (standard care). Data combined from these two studies showed the UV-treated group had a shorter mean time to complete healing than the control group (Nussbaum 1994; Wills 1983), with a mean difference of 2.13 weeks (95% CI -3.53 to -0.72) (P value 0.003; I2 0%) (Analysis 1.1). Data for the Nussbaum 1994 laser group were not pooled in this analysis due to use of a different wavelength; however, the laser group exhibited a non-significant increase in the time to complete healing when compared with the control group (mean difference 5.77 weeks; 95% CI -0.25 to 11.79). The comparative risk was shown as the Summary of findings for the main comparison. This result should be interpreted with caution as this is a small study and the finding may be due to chance. We also note that to analyse time to complete healing data using mean and standard deviation (SD) is a compromise due, in this case, to the absence of appropriate data in the original studies. We recognise that the exclusion of censored participants (participants for whom the outcome is unknown, or whose ulcer did not heal) is very likely to introduce bias. Schubert 2001 reported the percentage of ulcers that had not reached a certain level of ulcer healing at each weekly measurement by using the Kaplan-Meier method of survival analysis. The group receiving phototherapy achieved 90% healing in five weeks, compared with nine weeks for the control group.

Proportions/number of ulcers healed

Three studies reported the proportion of ulcers healed (Dehlin 2003; Durović 2008; Shojaei 2008). Dehlin 2003 reported the number of ulcers healed at 12 weeks as 43.6% (34/78) in the phototherapy group and 39.5% (34/86) in the placebo group; the healing risk ratio (RR) was 1.10 (95% CI 0.77 to 1.59). Durović 2008 reported complete wound healing at four weeks of 10% (2/20) for the phototherapy group and 50% (10/20) for the placebo group; the healing RR in favour of placebo was 0.20 (95% CI 0.05 to 0.80). We did not pool the results of these two studies (Dehlin 2003; Durović 2008), because of the different treatment durations ( Analysis 1.2). Shojaei 2008 reported that the difference in cure rate (minimum 50% reduction of ulcer size and improvement of at least one ulcer stage) between the two groups was statistically significant (P value 0.001) and in favour of the phototherapy group. There was a great deal of uncertainty surrounding these results, as the studies were small and all had an unclear risk of bias.

Adverse events/effects

Adverse effects were reported in two studies (Dehlin 2003; Lucas 2003). Dehlin 2003 reported 141 adverse events (participants n = 78) in the phototherapy group and 174 adverse events (participants n = 86) in the placebo group (RR 0.89, 95% CI: 0.71 to 1.12). Most of the adverse events were reported as unrelated to the treatment. Fve cases were considered related or possibly related to treatment, and these included tingling, pain, bleeding and redness. Lucas 2003, reported that 11% (5/44) of the participants in the control group and 8% (3/37) of the participants in the LLLT group developed a stage 4 decubitus ulcer during the six-week study period (Fisher's exact test: P value 0.72). The risk ratio for adverse events was imprecise (RR 0.72, 95%CI 0.18 to 2.80)( Analysis 1.3).

Secondary outcomes

Rate of healing in ulcer area

Five studies reported on rate of ulcer healing (Dehlin 2003; Lucas 2003; Nussbaum 1994; Schubert 2001; Shojaei 2008). Dehlin 2003 reported no difference in the rate of change in ulcer area between the two groups (P value 0.18). Lucas 2003 reported absolute (mm2) and relative (%) wound size reduction (over six weeks) which was analysed with Mann–Whitney U tests; there were no differences between the groups in either absolute improvement (P value 0.23) or relative improvement (P value 0.42) . Nussbaum 1994 reported the mean percentage change per week in ulcer size; 32.4% in the control group (six wounds), 53.5% in the US/UVC group (six wounds), and 23.7% in the laser group (six wounds). Schubert 2001 reported the rate of change in ulcer area (normalised ulcer area versus time); the healing rate was 39% greater in the phototherapy group compared to the control group. Shojaei 2008 reported downsizing of ulcers using the Wilcoxon test, and that there was no significant difference between groups (P value 0.236). Five studies reported the rate of change in ulcer area, three reported no difference between the groups. Whilst Schubert 2001 and Nussbaum 1994 reported improved healing for the phototherapy groups incomplete reporting of variance data means we are not able to verify these reports

Quality of life

Quality of life was not reported in any of the included trials.

Length of hospital stay

Length of hospital stay was not reported in any of the included trials.

Pain

Pain was not reported in any of the included trials.

Cost

Cost of treatment was not reported in any of the included trials.

Discussion

Summary of main results

Overall, there was insufficient evidence to determine the relative effects of phototherapy for healing pressure ulcers. All studies had small sample sizes, which may have resulted in underpowered studies. Increasing the study size, which can increase precision and reduce the impact of unusual responses, may change study results.

Overall completeness and applicability of evidence

Important secondary outcomes such as quality of life, length of hospital stay, pain, and costs were not reported in the included studies. Some of the studies included are old, which limits the generalisability of our findings, as phototherapy has developed significantly over recent years. The mainstream therapy of pressure ulcers is still conventional wound care. The included studies did not provide enough evidence to support the use phototherapy in targeted pressure ulcer patients. Future studies should have a longer follow-up period to enable the long term effectiveness of phototherapy to be assessed thoroughly, and should also include information about the costs of the different treatments.

Quality of the evidence

Overall the evidence was very low quality. Some methodological issues required consideration and limited the strength of the conclusions that could be drawn from this review. The studies were small and underpowered, the mean sample size was 58 (range 16 to 164) which resulted in wide confidence intervals. The interventions used in the studies were diverse and applied in various participant groups and different stages of pressure ulcers as shown in the Summary of findings for the main comparison. Blinding was poorly reported, with incomplete blinding of investigators, participants, outcome assessors, and the data analyst, in most trials. Lack of blinding can introduce bias, particularly when outcomes are subjective, and may lead to potential over-estimation of the effect of the intervention, resulting in bias in favour of the treatment (Day 2000). However, blinding of participants and caregivers is difficult to achieve in wound care; blinding of outcome assessors is possible, and was achieved in only one trial (Shojaei 2008). Dehlin 2003 attempted to blind patients by using sham phototherapy, and Wills 1983 applied mica to the ulcer area; it is unclear how successful these methods were. Of the remaining four studies, three studies were at high risk of performance bias and unclear risk of detection bias (Durović 2008; Lucas 2003; Nussbaum 1994). One study had unclear risk of performance bias and low risk of detection bias (Schubert 2001). This resulted in uncertainty about their risk of bias, as phototherapy and conventional therapy are different in both appearance and delivery.

Potential biases in the review process

There may be a risk of publication bias, as studies of phototherapy are frequently sponsored by the manufacturers of phototherapy devices. Results related to their products may not be published.

Agreements and disagreements with other studies or reviews

This review agrees with other related research with no evidence about the effect of phototherapy on wound healing (Hawkins 2007; Posten 2005; Sobanko 2008; Whinfield 2009). However, we found no other review that evaluated the specific therapeutic effects of phototherapy on pressure ulcers.

Authors' conclusions

Implications for practice

We are very uncertain as to the effects of phototherapy in the treatment of pressure ulcers. The small number of trials available for analysis, methodological limitations and small numbers of trial participants, meant that the possibility of benefits, or adverse effects, of this treatment cannot be ruled out. Overall, there was very low quality evidence about the effects of different approaches of phototherapy on treating pressure ulcers.

Implications for research

Trials comparing phototherapy with sham therapy, or standard care, are required to establish whether or not phototherapy improves the healing of pressure ulcers. In addition, future trials should explore whether particular sub-groups of participants are more likely than others to benefit from treatment with phototherapy, and, if the treatment is shown to be effective, to establish the point during the treatment regimen at which it should be applied. There is a need for further research in this area. It remains important that future studies be of sound methodological quality, and should incorporate the following.

  • True randomisation.

  • Adequate allocation concealment.

  • Blinded outcome assessment.

  • Use of objective outcome measurement (e.g. ulcer area, complete healing rates).

  • Intention-to-treat analysis.

  • Baseline comparability of groups (e.g. stratification for ulcer size or stage).

  • Adequate sample sizes that ensure sufficient statistical power to detect true treatment effects.

  • Reporting the results of the trial according to the CONSORT 2010 statement (Schulz 2010).

It is also recommended that studies should describe clearly the frequency and duration of treatment, location of wounds and any treatment applied concurrently with phototherapy.

Recruiting sufficient participants to participate in pressure ulcer studies can be difficult as many people with pressure ulcers appear to be incapacitated. Furthermore, when planning a trial in the pressure ulcer population, the death rate amongst participants during the study period is a major challenge. Ensuring sufficient participants are followed up to complete healing will always be difficult, and robust follow-up procedures need to take place. Potential solutions may involve exclusion of participants who are likely to die in the short-term, and use of survival analysis methods, which can use data from the participants up to the point of censoring (death). Nine of the 403 participants in the final analysis of these studies died during the trial period. If those withdrawn were taken into account after randomisation, seven out of 57 patients died. In modern inpatient settings, the movement of participants between wards and early discharge may pose alternative care risks compromising data collection. Given the considerable mortality rates in such short period of time in participants with pressure ulcers, healing may not be the most important outcome of interest. However, whether the patients will die or not may not be easy to predict at recruitment, and therefore in clinical practice the intervention would have to show benefit (both clinical and economic), even with such high death rates, as it is unlikely these patients would be denied treatment. More consideration should be given in future trials to quality of life and cost-effectiveness of the interventions, as these are important outcomes. There is a need to distinguish between the populations of participants with sacral, ischial and heel pressure ulcers, as the risk factors for healing in these differ, as well as the effects on a patient's quality of life.

Acknowledgements

The authors would like to thank the contribution of the peer referees, Cochrane Wounds Group Editors: Liz McInnes, Joan Webster, Gill Worthy and referees: Carol Dealey, Ruth Foxlee, Andrew Jull, Catriona McDaid, Liz McGinnis, Caroline Main, Zena Moore, Ruth Ropper and Marialena Trivella. In addition, the authors would like to thank Ruth Foxlee and Amanda Briant (Trial Search Co-ordinator) for running the search strategy, Sally Bell-Syer (Managing Editor) for co-ordination, checking the manuscript, editorial advice, Jenny Bellorini and Elizabeth Royle for copy-editing. Particular thanks go to Professor Nicky Cullum and Rachel Richardson for valuable feedback through the review's development. The authors also thank Anne Eskes, Jannick Dorresteijn, Margriet van Baar for translating non-English articles and providing valuable suggestions for inclusion/exclusion of studies. The authors would also like to thank Sally Green, Steve McDonald, Sharon Kramer, Jo McKenzie, and Matthew Page from the Australasian Cochrane Centre for great assistance during the Review Completion Workshop in Melbourne.

Data and analyses

Download statistical data

Comparison 1. Phototherapy versus control
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Time to complete healing (weeks)2 Mean Difference (IV, Random, 95% CI)Subtotals only
1.1 Ultra violet vs control224Mean Difference (IV, Random, 95% CI)-2.13 [-3.53, -0.72]
1.2 Laser vs control18Mean Difference (IV, Random, 95% CI)5.77 [-0.25, 11.79]
2 Proportions/number of ulcers healed2 Risk Ratio (M-H, Random, 95% CI)Totals not selected
3 Adverse events1 Risk Ratio (M-H, Random, 95% CI)Totals not selected
Analysis 1.1.

Comparison 1 Phototherapy versus control, Outcome 1 Time to complete healing (weeks).

Analysis 1.2.

Comparison 1 Phototherapy versus control, Outcome 2 Proportions/number of ulcers healed.

Analysis 1.3.

Comparison 1 Phototherapy versus control, Outcome 3 Adverse events.

Appendices

Appendix 1. Ovid MEDLINE search strategy

1 exp Pressure Ulcer/
2 (pressure adj (ulcer* or sore*)).tw.
3 (decubitus adj (ulcer* or sore*)).tw.
4 (bedsore* or bed sore*).tw.
5 chronic ulcer*.tw.
6 or/1-5
7 exp Phototherapy/
8 exp Laser Therapy/
9 (phototherap* or photoradiation therapy or photon therapy or light therapy).tw.
10 (pulse* adj3 light).tw. (974)
11 (pulse* adj3 (monochromic or monochromatic)).tw.
12 (light adj3 monochromatic).tw.
13 (wavelength adj3 light).tw.
14 (polarized adj3 light).tw.
15 (non-polarized adj3 light).tw.
16 (laser therapy or LLLT or LPLT or LILT or cold laser* or therapeutic laser* or light emitting diode* or LED or low reactive level laser* or diode laser*).tw.
17 or/7-16
18 6 and 17
19 randomized controlled trial.pt.
20 controlled clinical trial.pt.
21 randomized.ab.
22 placebo.ab.
23 clinical trials as topic.sh.
24 randomly.ab.
25 trial.ti.
26 or/19-25
27 (animals not (humans and animals)).sh.
28 26 not 27
29 18 and 28

Appendix 2. Ovid EMBASE search strategy

1 exp decubitus/ (9307)
2 (pressure adj (ulcer* or sore*)).tw. (5758)
3 (decubitus adj (ulcer* or sore*)).tw. (799)
4 (bedsore* or bed sore*).tw. (416)
5 chronic ulcer*.tw. (1463)
6 or/1-5 (11892)
7 exp phototherapy/ (39268)
8 exp Low Level Laser Therapy/ (9961)
9 (phototherap* or photoradiation therapy or photon therapy or light therapy).tw. (6263)
10 (pulse* adj3 light).tw. (2534)
11 (pulse adj3 (monochromic or monochromatic)).tw. (9)
12 (light adj3 monochromatic).tw. (515)
13 (wavelength adj3 light).tw. (1679)
14 (polarized adj3 light).tw. (2953)
15 (non-polarized adj3 light).tw. (14)
16 (laser therapy or LLLT or LPLT or LILT or cold laser* or therapeutic laser* or light emitting diode* or LED or low reactive level laser* or diode laser*).tw. (266174)
17 or/7-16 (308019)
18 6 and 17 (284)
19 Clinical trial/ (714455)
20 Randomized controlled trials/ (28044)
21 Random Allocation/ (50961)
22 Single-Blind Method/ (15709)
23 Double-Blind Method/ (86533)
24 Cross-Over Studies/ (32153)
25 Placebos/ (167510)
26 Randomi?ed controlled trial$.tw. (81537)
27 RCT.tw. (10784)
28 Random allocation.tw. (918)
29 Randomly allocated.tw. (14415)
30 Allocated randomly.tw. (1220)
31 (allocated adj2 random).tw. (265)
32 Single blind$.tw. (9760)
33 Double blind$.tw. (91286)
34 ((treble or triple) adj blind$).tw. (243)
35 Placebo$.tw. (138875)
36 Prospective Studies/ (203440)
37 or/19-36 (1068393)
38 Case study/ (16343)
39 Case report.tw. (168936)
40 Abstract report/ or letter/ (515163)
41 or/38-40 (696119)
42 37 not 41 (1039474)
43 animal/ (727596)
44 human/ (8724562)
45 43 not 44 (486704)
46 42 not 45 (1017156)
47 18 and 46 (57)
48 (2012* or 2013*).em. (1576450)
49 47 and 48 (4)

Appendix 3. EBSCO CINAHL search strategy

S31S18 and S30
S30S19 or S20 or S21 or S22 or S23 or S24 or S25 or S26 or S27 or S28 or S29
S29MH "Quantitative Studies"
S28TI placebo* or AB placebo*
S27MH "Placebos"
S26TI random* allocat* or AB random* allocat*
S25MH "Random Assignment"
S24TI randomi?ed control* trial* or AB randomi?ed control* trial*
S23AB ( singl* or doubl* or trebl* or tripl* ) and AB ( blind* or mask* )
S22TI ( singl* or doubl* or trebl* or tripl* ) and TI ( blind* or mask* )
S21TI clinic* N1 trial* or AB clinic* N1 trial*
S20PT Clinical trial
S19MH "Clinical Trials+"
S18S6 and S17
S17S7 or S8 or S9 or S10 or S11 or S12 or S13 or S14 or S15 or S16
S16TI (“laser therapy” or LLLT or LPLT or LILT or cold laser* or therapeutic laser* or light emitting diode* or LED or low reactive level laser* or diode laser*) or AB (“laser therapy” or LLLT or LPLT or LILT or cold laser* or therapeutic laser* or light emitting diode* or LED or low reactive level laser* or diode laser*)
S15TI non-polarized N3 light or AB non-polarized N3 light
S14TI polarized N3 light or AB polarized N3 light
S13TI light N3 wavelength or AB light N3 wavelength
S12TI light N3 monochromatic or AB light N3 monochromatic
S11TI (pulse* N3 monochromic or pulse* N3 monochromatic) or AB (pulse* N3 monochromic or pulse* N3 monochromatic)
S10TI pulse* N3 light or AB pulse* N3 light
S9TI ( phototherap* or "photoradiation therapy" or "photon therapy" or "light therapy" ) or AB ( phototherap* or "photoradiation therapy" or "photon therapy" or "light therapy" )
S8(MH "Laser Therapy+")
S7(MH "Phototherapy+")
S6S1 or S2 or S3 or S4 or S5
S5TI chronic ulcer* or AB chronic ulcer*
S4TI decubitus or AB decubitus
S3TI ( bed sore* or bedsore* ) or AB ( bed sore* or bedsore* )
S2TI ( pressure ulcer* or pressure sore* ) or AB ( pressure ulcer* or pressure sore* )
S1(MH "Pressure Ulcer")

Appendix 4. Risk of bias assessment

1. Was the allocation sequence randomly generated?

Low risk of bias

The investigators describe a random component in the sequence generation process such as: referring to a random number table; using a computer random number generator; coin tossing; shuffling cards or envelopes; throwing dice; drawing of lots.

High risk of bias

The investigators describe a non-random component in the sequence generation process. Usually, the description would involve some systematic, non-random approach, for example: sequence generated by odd or even date of birth; sequence generated by some rule based on date (or day) of admission; sequence generated by some rule based on hospital or clinic record number.

Unclear

Insufficient information provided about the sequence generation process to permit a judgement of low or high risk of bias.

2. Was the treatment allocation adequately concealed?

Low risk of bias

Participants and investigators enrolling participants could not foresee assignment because one of the following, or an equivalent method, was used to conceal allocation: central allocation (including telephone, web-based and pharmacy-controlled randomisation); sequentially-numbered drug containers of identical appearance; sequentially-numbered, opaque, sealed envelopes.

High risk of bias

Participants or investigators enrolling participants could possibly foresee assignments and thus introduce selection bias, such as allocation based on: using an open random allocation schedule (e.g. a list of random numbers); assignment envelopes were used without appropriate safeguards (e.g. if envelopes were unsealed or non­opaque or not sequentially-numbered); alternation or rotation; date of birth; case record number; any other explicitly unconcealed procedure.

Unclear

Insufficient information provided to permit a judgement of low or high risk of bias. This is usually the case if the method of concealment is not described or not described in sufficient detail to allow a definite judgement, for example if the use of assignment envelopes is described, but it remains unclear whether envelopes were sequentially-numbered, opaque and sealed.

3. Blinding - was knowledge of the allocated interventions adequately prevented during the study?

Low risk of bias

Any one of the following.

  • No blinding, but the review authors judge that the outcome and the outcome measurement are not likely to be influenced by lack of blinding.

  • Blinding of participants and key study personnel ensured, and unlikely that the blinding could have been broken.

  • Either participants or some key study personnel were not blinded, but outcome assessment was blinded and the non-blinding of others was unlikely to introduce bias.

High risk of bias

Any one of the following.

  • No blinding or incomplete blinding, and the outcome or outcome measurement is likely to be influenced by lack of blinding.

  • Blinding of key study participants and personnel attempted, but likely that the blinding could have been broken.

  • Either participants or some key study personnel were not blinded, and the non-blinding of others was likely to introduce bias.

Unclear

Either of the following.

  • Insufficient information provided to permit a judgement of low or high risk of bias.

  • The study did not address this outcome.

4. Were incomplete outcome data adequately addressed?

Low risk of bias

Any one of the following.

  • No missing outcome data.

  • Reasons for missing outcome data unlikely to be related to true outcome (for survival data, censoring unlikely to be introducing bias).

  • Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups.

  • For dichotomous outcome data, the proportion of missing outcomes compared with observed event risk was not enough to have a clinically relevant impact on the intervention effect estimate.

  • For continuous outcome data, plausible effect size (difference in means or standardised difference in means) among missing outcomes was not enough to have a clinically relevant impact on observed effect size.

  • Missing data have been imputed using appropriate methods.

High risk of bias

Any one of the following.

  • Reason for missing outcome data likely to be related to true outcome, with either imbalance in numbers or reasons for missing data across intervention groups.

  • For dichotomous outcome data, the proportion of missing outcomes compared with observed event risk enough to induce clinically relevant bias in intervention effect estimate.

  • For continuous outcome data, plausible effect size (difference in means or standardized difference in means) among missing outcomes enough to induce clinically relevant bias in observed effect size.

  • ‘As-treated’ analysis done with substantial departure of the intervention received from that assigned at randomisation.

  • Potentially inappropriate application of simple imputation.

Unclear

Either of the following.

  • Insufficient reporting of attrition/exclusions to permit a judgement of low or high risk of bias (e.g. number randomised not stated, no reasons for missing data provided).

  • The study did not address this outcome.

5. Are reports of the study free of suggestion of selective outcome reporting?

Low risk of bias

Either of the following.

  • The study protocol is available and all of the study’s pre-specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre-specified way.

  • The study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were pre-specified (convincing text of this nature may be uncommon).

High risk of bias

Any one of the following.

  • Not all of the study’s pre-specified primary outcomes have been reported.

  • One or more primary outcomes is reported using measurements, analysis methods or subsets of the data (e.g. subscales) that were not pre-specified.

  • One or more reported primary outcomes were not pre-specified (unless clear justification for their reporting is provided, such as an unexpected adverse effect).

  • One or more outcomes of interest in the review are reported incompletely so that they cannot be entered in a meta-analysis.

  • The study report fails to include results for a key outcome that would be expected to have been reported for such a study.

Unclear

Insufficient information provided to permit a judgement of low or high risk of bias. It is likely that the majority of studies will fall into this category.

6. Other sources of potential bias

Low risk of bias

The study appears to be free of other sources of bias.

High risk of bias

There is at least one important risk of bias. For example, the study:

  • had a potential source of bias related to the specific study design used; or

  • had extreme baseline imbalance; or

  • has been claimed to have been fraudulent; or

  • had some other problem.

Unclear

There may be a risk of bias, but there is either:

  • insufficient information to assess whether an important risk of bias exists; or

  • insufficient rationale or evidence that an identified problem will introduce bias.

Contributions of authors

Chiehfeng Chen: conceived, designed and co-ordinated the review. Extracted data, assessed quality, analysed and interpreted data. Performed statistical analysis and checked quality of statistical analysis. Wrote and edited the review. Secured funding and performed previous work that was the foundation of the current review. Wrote to study authors, experts and companies. Approved final review prior to submission and is a guarantor of the review.
Wen-Hsuan Hou: conceived, designed and co-ordinated the review. Extracted data, assessed quality, analysed and interpreted data. Performed statistical analysis. Completed the first draft of the review, advised on the review and approved final review prior to submission.
Edwin SY Chan: conceived and designed the review. Checked quality of data extraction and checked quality assessment. Checked quality of statistical analysis. Advised on and made an intellectual contribution to the review. Approved final review prior to submission.
Mei-Ling Yeh: conceived and designed the review. Extracted data and assessed quality, analysed and interpreted data. Performed statistical analysis. Advised on the review and approved final review prior to submission.
Heng-Lien Daniel Lo: co-ordinated the review. Extracted data and checked quality of data extraction. Analysed and interpreted data. Performed statistical analysis. Completed first draft of the review and contributed to writing and editing the review. Advised on the review and approved final review prior to submission.

Contributions of editorial base

Joan Webster: Approved the final review prior to submission.
Sally Bell-Syer: co-ordinated the editorial process. Advised on methodology, interpretation and content. Edited the review.
Rachel Richardson: edited the review.
Ruth Foxlee: designed the search strategy.
Amanda Briant: ran the searches and edited the search methods section for the review.

Declarations of interest

Chiehfeng Chen: nothing to declare
Wen-Hsuan Hou: nothing to declare
Edwin SY Chan: nothing to declare
Mei-Ling Yeh: nothing to declare
Heng-Lien Daniel Lo: nothing to declare

Sources of support

Internal sources

  • No sources of support supplied

External sources

  • The National Health Institute for Health Research (NIHR) is the sole funder of the Cochrane Wounds Review Group, UK.

Differences between protocol and review

We did not perform the subgroup analyses to test the effect of study quality, participants and setting on the outcome because of limited data reported in the included studies.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Dehlin 2003

MethodsRCT
Participants164 (57 M; 107 F) participants in 8 geriatric centres with a grade II (87 participants) or grade III (77 participants) pressure ulcer. Ulcers were located on the trunk (74) and foot (90). Ulcer staging was defined by Shea Score (Shea 1975). Mobility status included "bedridden or wheelchair-bound" (104) and "walking with support" (59). The study was conducted in Sweden and Denmark
Interventions

Phototherapy group (n = 78): pulsed monochromatic light (Biolight® International AB, Sweden)

A probe containing IR light at 956 nm and red light at 637 nm was pulsed at the following frequencies with

a duty cycle of 80%:

infrared light: 287 Hz, 31.2 Hz, 9900 Hz, 8 Hz, 15.6 Hz and 780 Hz;

Red light: 8 Hz, 31.2 Hz, 9900 Hz, 5 Hz and 8.6 Hz

IR at 55 W/m2 was given first, and then red light at 21 W/m2

Placebo group: (n = 86) white light diode painted red

Both groups (placebo or phototherapy) were administrated according to fixed scheme: 5 days during week 1; 2 days during weeks 2, 3, 6, 8 and 10; and 3 days during week 3, 5, 7, 9 and 11. No phototherapy was administered on Saturdays or Sundays. Treatment duration was 9 min for the first 5 sessions (week 1) and 6 min for all remaining sessions

Local wound treatment: all participants received the same conventional treatment, i.e. protection of the ulcer area, a regular turning schedule, emollient or moisturising cream around the ulcer, a pressure-reducing mattress, and a pressure-reducing cushion for wheelchair-bound participants. Hydrocellular/hydrocolloid bandages (Comfeel, Coloplast, Thigaderm) were applied to clean ulcers. Chemical or enzymatic debridement was not allowed

Outcomes

PRIMARY OUTCOMES:

a) Number of ulcers healed at 12 weeks:

b) Rate of change in ulcer area

c) Time to complete healing (weeks)

SECONDARY OUTCOME:

d) Adverse effects:

NotesThis study was supported by Biolight Internal AB
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskComment: although the authors described this is a double-blind, randomised, placebo-controlled study, the process of randomisation was not clear and only mentioned in passing, "2 (patients) because their pressure ulcer healed after screening but before randomisation" (p 260)
Allocation concealment (selection bias)Unclear riskComment: no description of the process of allocation concealment provided
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskComment: interventions in 2 groups described as "The equipment for phototherapy and placebo was identical in appearance and both emitted red light. Intervention emitted both red light and infrared light. Placebo only emitted red light. No heating was seen from either treatment", which means that blinding of participants was possible (p 261). The blinding of personnel was not mentioned
Blinding of outcome assessment (detection bias)
All outcomes
Low riskComment: the authors stated, "the ulcer area of patients in all centres was determined by an independent individual using a planimeter . . . " (p 261)
Incomplete outcome data (attrition bias)
All outcomes
Low riskComment: reasons for missing outcome data unlikely to be related to true outcome. 34 (17%) dropped out mainly due to protocol violation, a wish to withdraw, or because they experienced adverse events
Selective reporting (reporting bias)High riskComment: the study protocol mentioned that grade II or III pressure ulcers were included, however, only the results of the grade II ulcers were reported in Figure 1
Other biasUnclear riskComment: Exclusion criteria for this study lack of sufficient rationale and is likely to introduce other bias (p 260)

Durović 2008

MethodsRCT
Participants

Recruited 48 participants with several kinds and locations of pressure ulcers. 4 participants refused to take part in the study, 2 participants were withdrawn from the phototherapy group and 2 participants in the control group died in second and third weeks of treatment

Ulcers were located on the low part of back (1), right-low part of back (1), right buttock (1), left buttock (2), both buttocks (2), sacral area (15), right sacral-buttock area (1), right iliac spine (1), left hip (6), right hip (1), right heel (5), left heel (4)

Inclusion criteria: people with a stage I–III ulcer according the Pressure Ulcer Classification System. No report on participants' mobility status

This study was conducted in Serbia

Interventions

Phototherapy group (n = 20): polarised light therapy (Bioptron lamp) plus standard cleaning and dressing. A linear polarised light was used at wavelength: 400–2000 nm; degree of polarisation: > 95%; power density: 40 mW/cm2; light energy: 2.4 J/cm2, for 6 min daily, at a distance of 10 cm, 5 times a week. Before the polarised light therapy, each wound was splashed with oxygen spray. All therapies were performed between 14:00 h and 16:00 h. Treatment lasted 4 weeks. All wounds were cleaned using 2% hydrogen peroxide.

Control group (n = 20): standard cleaning and dressing only, i.e. gauze with normal saline (NaCl), then a dry gauze, next to it a cotton wool and adhesive strip

Outcomes

PRIMARY OUTCOME:

a) Completely healing of wound at 4 weeks

SECONDARY OUTCOMES:

b) Amount of exudate

c) Wound surface

NotesInformation about study funding was not provided
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComment: probably done. The paper mentioned "the random divide was performed by the random number table" (p 907)
Allocation concealment (selection bias)Unclear riskComment: no details provided about the strategy used to conceal allocation of participants
Blinding of participants and personnel (performance bias)
All outcomes
High riskComment: this was a single blind study. The nature of the intervention under investigation makes blinding of participants and clinical professionals difficult
Blinding of outcome assessment (detection bias)
All outcomes
Low riskComment:described in methods section as "wound healing process was evaluated in a standard manner by two independent blinded observers" (p 908)
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskComment: 2 participants withdrawn from both experimental and control groups. The reasons differed across groups: the two from the control group died, which may have been related to having a pressure ulcer. The later analysis is per-protocol rather than intention-to-treat
Selective reporting (reporting bias)Low riskComment: all study outcomes have been reported
Other biasHigh riskComment: participants significantly worse in the control group for 2 important baseline outcome measurements (surface and total PUSH score of pressure ulcer), which may have affected the treatment effect. Small sample size (n = 40) may have been a potential source of bias

Lucas 2003

MethodsRCT
Participants

Recruited 86 (32 M; 54 F) participants with a stage III pressure ulcer, from 3 nursing homes. Ulcers were located on the sacrum/coccyx (28), calcaneus (27), gluteal (12) , lateral malleolus (8), greater trochanter (1), medial femoral condyle (1), and other locations (9)

Decubitus ulcer stage III was defined as a full-thickness skin defect extending into the subcutaneous layers and adipose tissue (NPUAP 1989). No report on participants' mobility status

This study was conducted in Netherlands

Interventions

Phototherapy group (n = 39): LLLT treatments administered using a 12 microprocessor-controlled infrared Ga-AS-diode laser probe at 904 nm, covering an irradiated area of 12 cm2 (physical probe dimension 30 cm2). Total peak power was 12x70 W in a 830 Hz pulse frequency mode of 150 ns pulses with an average beam power of 12x8 mW and a radiant exposure of 1 J/cm2, which required an exposure time of 125 s. The laser probe was applied to the surrounding normal tissue surface as a contact treatment, so that the centre of the applicator was held just off contact with the wound surface area (distance ≤ 1 mm). The beams, with a 2.5° angle of divergence, were applied perpendicularly to the tissue to achieve maximal penetration. Equal beam power was guaranteed by using lasers from 1 production process, which were calibrated in one machine(Combilaser C-501, Schreuder Medical, Amersfoort, the Netherlands)

Control group (n = 47): conventional therapy

All participants received the prevailing consensus decubitus ulcer treatment, as developed and recommended by NPUAP

Outcomes

PRIMARY OUTCOME:

a) Absolute (mm2) and relative (%) wound size reduction at 6 weeks compared to baseline.

SECONDARY OUTCOMES:

b) the number of participants developing a stage IV ulcer

c) the median change in Norton scores

d) Adverse effects

NotesInformation about funding of this study was not provided
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskComment: the study states "all patients were randomly assigned to one of the two treatment protocols: the control group or the experimental group" (p 73)
Allocation concealment (selection bias)Low riskComment: the authors stated "allocation was by means of a central computerized telephone service.”
Blinding of participants and personnel (performance bias)
All outcomes
High riskComment: the authors did not provide information about how the participants and caregivers were blinded during the trial; there was no sham procedure for the control group, which meant that blinding was at high risk of bias
Blinding of outcome assessment (detection bias)
All outcomes
Low riskComment: authors stated "We performed a prospective, observer-blinded multicentre randomised clinical trail to assess the effect of . . .", also other information showed in methods session as "an investigator, not involved in the treatment, checked the output of the diode lasers every 2 months . . ." (p 73)
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk

Comment: primary outcome wound size and secondary outcome Norton score: 1/47 (2.12%) missing from control group 1/39 (2.56%) missing from intervention group. Missing outcome data balanced in numbers across 2 groups with similar reasons

Secondary outcome stage IV ulcer: 3/47 (6.38%) missing from control group; 2/39 (5.12%) missing from intervention group. Missing outcome data balanced in numbers across 2 groups with similar reasons

Although the authors mentioned that analysis was based on the intention-to-treat principle, the result provided was a per-protocol analysis for each group

Selective reporting (reporting bias)Low riskComment: all study outcomes have been reported
Other biasLow riskComment: the study appears to be free of other sources of bias

Nussbaum 1994

MethodsRCT
Participants

Hospitalised patients at Lyndhurst Spinal Cord Centre with a diagnosis of SCI and skin wounds. Participants' ulcers were located on the coccyx (5), ankle (4), trochanter (3), chest (2), ischium (1), calf (1), heel (1), and thigh (1). Ulcer stages not defined. No report on participants' mobility status

20 participants (22 wounds) were randomly assigned to 3 groups

This study was conducted in Canada

Interventions

US/UVC group (n = 5): pulsed US applied at a frequency of 3 MHz and a spatial average-temporal average intensity of 0.2 W/cm2 (1:4 pulse ratio) for 5 minutes per 5 cm2 of wound area. The UVC dosage (95% emission at 250 nm) was calculated for each session according to wound appearance. The dosage level was E1 for clean/granulating areas, E3 for purulent/slow-granulating areas, E4 for heavily infected areas, and 2E4 for wound debridement

Laser group (n = 6): Treatment was applied three times weekly using a cluster probe with an 820 nm laser diode and 30 superluminous diodes (10 at 660 nm, 880 nm, and 950 nm), and energy density of 4 J/cm2, and a pulse repetition rate of 5000 pulses/s

Wounds were traced every 14 days, and surface areas were calculated using the Sigma-Scan Measurement System

Control group (n = 9): received standard wound care, consisting of wound cleansing twice daily using Hygeol (1:20), Jelonet dressings to keep the wound surface moist, and avoidance of lying or sitting positions that would cause pressure on existing ulcers.

A total of 16 participants (18 wounds) in both groups received standard wound care consisting of wound cleaning twice daily, application of moist dressings, and continuous relief of pressure until the wounds were healed.

Outcomes

PRIMARY OUTCOME:

a) time to complete healing

SECONDARY OUTCOMES:

b) mean percentage changes per week in ulcer size

c) Adverse effects: no adverse effects reported

NotesThe study was funded by the John Labatt Seed Fund Award
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskComment: the study only mentioned "patients who gave informed consent were randomly assigned . . . ” p 814
Allocation concealment (selection bias)Unclear riskComment: not addressed
Blinding of participants and personnel (performance bias)
All outcomes
High riskComment: the authors did not provide information about how the patient and caregivers were blinded during the trial; there was no sham procedure in the control group, which meant that blinding was at high risk of bias
Blinding of outcome assessment (detection bias)
All outcomes
Low riskComment: the paper states "one investigator (ELN) was blinded to the subjects' group assignment" (p 816) and "All tracings were made by one investigator (ELN) who was not employed at the spinal cord centre and was blind to the subjects' group assignments. At the end of the study, the same investigator analysed the tracings using a digitiser tablet and stylus pen."
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskComment: 4 participants (4/20, 20%) did not complete the study
Selective reporting (reporting bias)Low riskComment: all study outcomes have been reported
Other biasUnclear riskComment: small sample size (only 16 were analysed, although 20 recruited) and analysis based on wound rather than patient which may have been a potential source of bias

Schubert 2001

MethodsRCT
Participants

72 (26 M; 46 F) participants at the Huddings University Hospital in Sweden with stage II or III pressure ulcer. Most participants had falling trauma, which in 82% resulted in a fracture or an operation prior to the investigation. 54 participants had pressure ulcers located on the trunk. Ulcer staging was defined by Shea Score (Shea 1975). No mobility status was reported

This study was conducted in Sweden

Interventions

Phototherapy group (n = 35): pulsed monochromatic light (Biolight® International AB, Sweden)

A probe contained both 30 diodes, which emit IR light at 956 nm, and 80 diodes, which emit red light at 637 nm. First, it applied IR light with an irradiance of 55 W/m2 (light dose rate measured with a Photo Research SpectraScanA Model PR–714), then red light with an irradiance of 21 W/m2 (light dose rate measured with a SpectraScanA Colorimeter Model PR–650). Using a duty cycle of 80%, both the IR light and the red light were pulsed with the following pulse frequencies: for the first 5 treatments: 78 Hz, 702 Hz, 8.58 kHz; and for following treatments: 15.6 Hz, 287 Hz, 31.2 Hz. The probe was held approximately 3 cm above the ulcer, and was advanced around the ulcer surface to ensure even illumination of the whole area. Treatments were given for 9 min each time by 2 trained nurses. The number of treatments/week were: 5 in week 1; 4 in week 2; 2 in week 3; 1 in week 4 and beyond

Placebo group (n = 37): conventional therapy only

Both groups were given the same preventive information and local ulcer therapy prescribed by the investigator

Local wound treatment: all participants received the same conventional treatment: protection of the ulcer area, a regular turning schedule, emollient or moisturising cream around the ulcer, a pressure-reducing mattress, and a pressure-reducing cushion for wheelchair-bound participants. Hydrocellular/hydrocolloid bandages (Comfeel, Coloplast, Thigaderm) were applied to clean ulcers. Chemical or enzymatic debridement was not allowed

Outcomes

PRIMARY OUTCOMES:

a) Rate of change in ulcer area (normalised ulcer area versus time)

b) Healing rate per week

SECONDARY OUTCOME:

c) Survival curves calculated with the Kaplan-Meier method to evaluate along with the ulcer healing progress

NotesFinancial support for this study was provided by Karolinska Institutet, Gun and Bertil Stohne's Foundation, and BiolightTM International AB
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskComment: the study only mentioned "Randomisation was carried out in random permuted blocks of six patients prepared in advance" (p 33)
Allocation concealment (selection bias)Unclear riskComment: probably not done since no further details provided about whether the randomising schedule or assigning envelopes had appropriate safeguards
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskComment: authors did not provided information regarding blinding
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskComment: the study did not report whether outcome assessor knew to which group participants belonged
Incomplete outcome data (attrition bias)
All outcomes
Low riskComment: 1 participant interrupted the study in week 5. 3 patients died during the course of the study, and 1 patient was not accessible for measurements for the last 2 weeks in control group. In phototherapy, 1 patient was further excluded after week 2 due to reoperation. Six patients died during the course of the study, and one patient was not accessible for measurements for the last 2 weeks.
Selective reporting (reporting bias)Low riskComment: all study outcomes have been reported
Other biasUnclear riskInsufficient information provided to assess whether an important bias exists

Shojaei 2008

MethodsRCT
Participants

Recruited 16 SCI veterans in Tehran with stage I (9 participants), II (4 participants) and III (3 participants) pressure ulcers in the following locations: ischial (10), sacral (4), and ankle (2). No report on participants' mobility status

This study was conducted in Iran

Interventions

Phototherapy group (n = 8): supportive treatment and laser treatment using a GA-AL-AS laser and GA-AL-IN-PH diode laser (Azor-2k, Russia). Applied with contact using a continuous emission mode with probes: IR: 980 nm, 200 mW continuous (GA-AL-AS); and red light: 650 nm, 30 mW continuous (GA-AL-IN-PH). A dose of 4-6 J/cm2 was applied every other day for 3 weeks

Control group (n = 8): supportive treatment only

Outcomes

PRIMARY OUTCOMES:

a) Reducing the size of ('downsizing') the ulcers

b) Ulcer stage before and after treatment

SECONDARY OUTCOMES:

c) Ulcer size difference: comparing the ulcer size before and after treatment in both groups

d) Reducing the size of ulcer: comparing the effect of treatment in reducing the size of ulcer in both groups

e) Stage downgrade;

f) The minimum 50% reduction in ulcer size;

g) The difference of cure rate.

NotesSource of funding for the trial was not reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskComment: the study only mentioned "they were selected in a convenient method and were randomly divided into case and control groups" (p 45)
Allocation concealment (selection bias)Unclear riskComment: probably not done, since no further details are provided about whether the randomising schedule or assigning envelopes had appropriate safeguards
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskComment: trial authors stated "The experimental study was designed as a randomised clinical trial with control and intervention groups in a triple blind setting" (p 45). However, the authors did not provided details of how the participants and caregivers were blinded during the trial; the absence of a sham procedure in the control group means that there is an unclear risk of bias for blinding
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskComment: trial authors stated " The data were filled into a form and were analysed by a statistician in a blind setting . . . " (p 45) However, the wound assessment process was not described
Incomplete outcome data (attrition bias)
All outcomes
Low riskComment: no missing outcome data in current study
Selective reporting (reporting bias)Low riskComment: all study outcomes have been reported
Other biasUnclear risk

Groups were not comparative at baseline with regard to stage of pressure ulcers. There were fewer stage 1 pressure ulcers in the control group (37.5%) than in the phototherapy group (75%) (p 46).

The small sample size (n = 16) may have been a potential source of bias

Wills 1983

  1. a

    Abbreviations

    < = less than
    ≤ = less than or equal to
    F = female
    GA-AS = gallium-arsenide
    GA-AL-AS = gallium-aluminium-arsenide
    GA-AL-IN-PH = gallium-aluminium-indium-phosphate
    h = hour(s)
    IR = infrared
    LLLT = low-level laser therapy
    M = male
    min = minute(s)
    NPUAP = (American) National Pressure Ulcer Advisory Panel
    PUSH = Pressure Ulcer Scale for Healing
    RCT = randomised controlled trial
    s = second(s)
    SCI = spinal cord injury
    UV = ultraviolet
    UVC = ultraviolet C
    US = ultrasound

MethodsRCT
Participants

16 (6 M; 10 F) elderly participants residing in the Extended Care Unit of the Health Sciences Centre Hospital at the University of British Columbia and suffering from superficial pressure sores of recent onset of < 5 mm. 13 participants (81%) had ulcers located on ischium or sacrum. Ulcer stages were not defined. No report on participants' mobility status

This study was conducted in Canada

Interventions

Phototherapy group (n = 8): conventional treatment and UV light treatment 2 times a week with doses 2.5 minimal erythemal dosage (comparable to second degree erythema). The full course was 10 weeks. The UV source was a Kromayer lamp, i.e. a water-cooled mercury vapour lamp suitable for local irradiation (200–400 nm) that can be used in direct contact with the skin

Control group (n = 8): conventional treatment only

Outcomes

PRIMARY OUTCOME:

a) Time to complete healing

SECONDARY OUTCOME:

b) Adverse effects

NotesThis study was supported by a grant from the Canadian Geriatrics Research Society
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskComment: the study only mentioned "patients were randomly allocated to a treatment group . . ." (p131)
Allocation concealment (selection bias)Unclear riskComment: no further details regarding allocation concealment provided
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskComment: the authors did not provide details about how the participants and caregivers were blinded during the trial: there was no sham procedure in the control group which makes the trial high risk for blinding. Although the authors described " . . . both patients and hospital staff were blind as to individual allocation" and the intervention in the control group was "the UV light was completely obstructed by a mica cap left in place over the quartz window" (p131-2) which could blind the patients , however, might not blind very well for staff.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskComment: report states "No staff member was aware of the treatment category to which each patient belonged . . . " (p 132)
Incomplete outcome data (attrition bias)
All outcomes
Low riskQuotation: "One died and one was transferred to an acute care hospital" (p 132)
Selective reporting (reporting bias)Unclear riskComment: insufficient information provided to make a judgment
Other biasUnclear riskComment: small sample size (n = 18) may have been a potential source of bias

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
Dolan 1989The report for this trial was written in Dutch. In this study, participants were selected randomly and divided into groups using a list (not specified further). However, participants did not receive the treatment allocated because of ethical problems. Initially, 4 groups were randomly selected and had to be classified as a list. However, those participants with smaller wounds for whom favourable progress was expected, were then reassigned to the placebo and control groups. Therefore, the number of participants in control and placebo groups were much smaller compared to the intervention groups. The poor quality of the data reported led to difficulties with interpretation of data
Iordanou 2002This study examined the effect of polarised light on pressure ulcers in participants with 2 pressure ulcers. The process by which each ulcer was assigned to a group is not clear. Since phototherapy may have a systemic effect, it may be difficult to separate out the true effect between the 2 groups. This study was excluded because, according to our review protocol, the required unit for inclusion in the review is participants, not ulcers
Mol 1994The report for this study was written in Dutch. This study was not randomised or quasi-randomised. The authors state that an independent co-worker allocated participants to the intervention and control groups, ensuring equal wound surface and male:female ratio in both groups
Nussbaum 2013This study examined the effect of UVC irradiation on pressure ulcers in participants with 1 or more pressure ulcers. We excluded the study because reporting of outcomes was based on ulcers instead of participants. In our protocol, the required unit for inclusion in the review is participants, not ulcers
Onigbinde 2010The study design was a non-randomised matched cohort design
Taly 2004This study examined the effect of multi-wavelength light therapy on pressure ulcers in participants who might have had more than one ulcer. The process of randomisation was based on ulcers rather than participants, which contravenes our requirements for inclusion in the review. Furthermore, since phototherapy may have a systemic effect, it could be difficult to separate out the true effect of phototherapy treatment

Characteristics of studies awaiting assessment [ordered by study ID]

Dehlin 2007

MethodsPaper that presents a combined analysis from 2 trials that were conducted at different time periods (see Notes)
Participants

163 (62 M; 101 F) participants in 8 geriatric centres with a grade II pressure ulcer. Ulcers were located on the trunk (92) or foot (71). Ulcer staging defined by Shea Score. Mobility status included "bedridden or wheelchair-bound" (88) and "walking with support" (62). The study was conducted in Sweden and Denmark

87 of the participants in the analysis were from a previous study (Dehlin 2003), and the remainder from the more recent study (Dehlin 2007).

Interventions

Phototherapy group (n = 78): pulsed monochromatic light (Biolight® International AB, Sweden) using a probe containing IR light at 956 nm and red light at 637 nm pulsing at the following frequencies:

IR: 287 Hz, 31.2 Hz, 9900 Hz, 8 Hz, 156 Hz

red light: 8 Hz, 31.2 Hz, 9900 Hz, 5 Hz and 8.6 Hz.

IR 55 W/m2 given first, then red light 21W/m2

Placebo group (n = 86): white light diode painted red

Intervention for both groups was administrated according to fixed schedule: 5 days for week 1; 2 days for weeks 2, 3, 6, 8 and 10; 3 days for weeks 3, 5, 7, 9 and 11. No phototherapy was administered on Saturdays or Sundays. Treatment duration was 9 min for the first 5 sessions (week 1) and 6 min for all remaining sessions

Local wound treatment: all participants received the same conventional treatment: protection of the ulcer area, a regular turning schedule, emollient or moisturising cream around the ulcer, a pressure-reducing mattress, and a pressure-reducing cushion for wheelchair-bound participants. Hydrocellular/hydrocolloid bandages (Comfeel, Coloplast, Thigaderm) were applied to clean ulcers. Chemical or enzymatic debridement was not allowed

Outcomes

PRIMARY OUTCOME:

a) Rate of change in ulcer area (the mean normalised reduction in pressure ulcer size)

SECONDARY OUTCOMES:

b) Number of ulcers healed at 12 weeks

c) Time to complete healing (days)

d) Adverse effects

NotesThis study presents the combined analysis of results from 87 participants with grade II ulcers from a previous study, Dehlin 2003, with 76 participants from a trial conducted several years later. We have written to the author requesting the data for the 76 participants randomised in the subsequent study so that these data can be presented separately in the meta-analysis

Lucas 2000

  1. a

    Abbreviations

    F = female
    M = male
    RCT = randomised controlled trial
    min = minute(s)

MethodsRCT
ParticipantsConsecutive patients with stage III pressure ulcers were eligible from 4 nursing homes. This study was conducted in Netherlands.
InterventionsAll patients received the prevailing consensus decubitus ulcer treatment; whereas one group(n=8) had LLLT in addition. LLLT treatments were administered using an LLLT device with a microprocessor controlled optical source probe.The control group (n=8) was provided with the standard treatment only.
Outcomes

PRIMARY OUTCOME:

No treatment-related adverse effects were reported during this study.

SECONDARY OUTCOME:

the median wound area (mm2) at six weeks after the intervention startedChange of wound surface area

NotesWe checked the study period and settings between Lucas 2000 and Lucas 2003 and found that study subjects and data in Lucas 2000 was unclear and may overlapping with the Lucas 2003. We moved Lucas 2000 to the section of studies awaiting classification.

Ancillary