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Dressings and topical agents for preventing pressure ulcers

  1. Zena EH Moore1,*,
  2. Joan Webster2,3,4

Editorial Group: Cochrane Wounds Group

Published Online: 18 AUG 2013

Assessed as up-to-date: 1 FEB 2013

DOI: 10.1002/14651858.CD009362.pub2


How to Cite

Moore ZEH, Webster J. Dressings and topical agents for preventing pressure ulcers. Cochrane Database of Systematic Reviews 2013, Issue 8. Art. No.: CD009362. DOI: 10.1002/14651858.CD009362.pub2.

Author Information

  1. 1

    Royal College of Surgeons in Ireland, School of Nursing & Midwifery, Dublin, Ireland

  2. 2

    Royal Brisbane and Women's Hospital, Centre for Clinical Nursing, Brisbane, Queensland, Australia

  3. 3

    Griffith University, NHMRC Centre of Research Excellence in Nursing, Centre for Health Practice Innovation, Menzies Health Institute Queensland, Brisbane, Queensland, Australia

  4. 4

    University of Queensland, School of Nursing and Midwifery, Brisbane, Queensland, Australia

*Zena EH Moore, School of Nursing & Midwifery, Royal College of Surgeons in Ireland, 123 St. Stephen's Green, Dublin, D2, Ireland. zmoore@rcsi.ie.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 18 AUG 2013

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Characteristics of included studies [ordered by study ID]
Green 1974

MethodsDouble blind RCT, with 3-week follow-up, method of randomisation not stated


Participants319 geriatric participants from 6 geriatric departments in the UK


InterventionsTopical agent trial

Group 1 (intervention): active lotion containing: hexachlorophane 0.5%, saturated hydrocarbons (squalene (Cosbiol 3%) and

glyoxyle diureide), allantoin 0.2%, antioxidants, lanolin, fatty acids, fatty acid esters, fatty alcohols, preservatives and distilled water

Group 2 (control): inert lotion containing: lanolin, fatty acids, fatty acid esters, fatty alcohols, preservatives, distilled water and mineral oils

Lotions applied with fingers to pressure areas (sacral, trochanteric, heel and shoulder and other areas as indicated). Excess friction avoided. Skin inspected every 2 h, participant turned and changed if soiled, washed with soap and water, skin dried and lotion applied after each cleansing. In the absence of incontinence, routine washing and reapplication of lotion was carried out every 6 h.

Bed cradles used for all participants to keep the weight of the bedding off the feet and lower legs.

Participants with a score of 10 or less (clinical at risk score) were nursed on a large cell alternating pressure mattress


OutcomesThe outcome of interest was pressure ulcer incidence, noted as either erythema or superficial sores


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNot stated

Allocation concealment (selection bias)Unclear riskNot stated

Blinding of participants and personnel (performance bias)
All outcomes
Low riskEvidence for participants: blinded

Comment: quote: "The active and inert lotions were similar in appearance and texture. They were randomly dispensed in identical plastic squeeze bottles to avoid possible bias of application"

Evidence for personnel: blinded

Comment: quote: "The active and inert lotions were similar in appearance and texture. They were randomly dispensed in identical plastic squeeze bottles to avoid possible bias of application, or other nursing procedures"

Blinding of outcome assessment (detection bias)
All outcomes
Low riskEvidence for outcomes: blinded

Comment: quote: "The active and inert lotions were similar in appearance and texture. They were randomly dispensed in identical plastic squeeze bottles to avoid possible bias of application, or other nursing procedures, and of the research nurses observations"

Incomplete outcome data (attrition bias)
All outcomes
High riskITT not conducted, 152 participants excluded

Selective reporting (reporting bias)Low riskEvidence: pressure ulcers described as erythema or superficial in the results

Comment: pressure ulcers of greater than grade 2 were grounds for discontinuation of trial

Other biasLow risk

Han 2011

MethodsRCT, follow-up 72 hours.


Participants100 people admitted for posterior spinal surgery in Shandong, China. The study excluded people with previous skin disease, those undergoing emergency surgery, and those with operation time of < 3 h. Follow-up at 24 h and 72 h post surgery.


InterventionsDressing trial

Intervention group: Kang’ Huier transparent strip and foam dressing

Control group: routine operating room protective measures


OutcomesPressure ulcer incidence


NotesAuthors state that the 2 pressure ulcers in the intervention group occurred outside the treated area


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskEvidence for outcomes: not described

Comment: states only that participants were randomly grouped. But authors did not explain how the sequence was generated

Allocation concealment (selection bias)Unclear riskEvidence for outcomes: not described

Blinding of participants and personnel (performance bias)
All outcomes
High riskEvidence for outcomes: blinding impossible due to the nature of the intervention

Blinding of outcome assessment (detection bias)
All outcomes
High riskEvidence for outcomes: blinding impossible due to the nature of the intervention.

Incomplete outcome data (attrition bias)
All outcomes
Low riskComment: 100 participants enrolled and all accounted for in the results

Selective reporting (reporting bias)Low riskEvidence for outcomes: the only outcome pre-specified was 'pressure sore'.

Other biasUnclear riskComment: We had only the most important data interpreted. It is possible that there may have been biases about which we are unaware.

Houwing 2008

MethodsCluster RCT, 4-week follow-up, randomly assigned at ward level not at participant level. Exact method of randomisation not stated


Participants79 participants at risk of development of pressure ulcers, in 8 nursing homes in the Netherlands


InterventionsTopical agent trial

Group 1 (intervention): massage using a “DMSO-cream.” This cream consisted of 5% dimethyl sulfoxide in Vaseline-cetomacrogol cream, combined with a 30o position change. This procedure was repeated every 6 h for 4 weeks

Group 2 (placebo): 3-minute massage of the buttock, heel, and ankle regions with an indifferent cream (Vaseline-cetomacrogol) combined with a 30o position change. This procedure was repeated every 6 h for 4 weeks.

Group 3 (control): 30o position change, repeated every 6 h for 4 weeks


OutcomesPressure ulcer incidence


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskThrow of a dice (additional information from the author)

Allocation concealment (selection bias)Unclear riskNot stated

Blinding of participants and personnel (performance bias)
All outcomes
Low riskEvidence for participants: stated as double blind

Comment: stated as double blind

Evidence for personnel: stated as double blind

Comment: stated as double blind

Blinding of outcome assessment (detection bias)
All outcomes
Low riskEvidence for outcomes: blinded

Comment: quote: "presence of a pressure ulcer confirmed by two external observers"

Incomplete outcome data (attrition bias)
All outcomes
Low riskEvidence: none excluded

Selective reporting (reporting bias)Low riskEvidence: outcome measure was the presence of a pressure ulcer

Comment: this was reported by the authors

Other biasLow risk

Kalowes 2012

MethodsProspective RCT


Participants367 people nursed in a medical/surgical/trauma intensive care unit and a cardiac intensive care unit


InterventionsDressing trial

Group 1 (intervention): silicone foam dressing and SKIN care bundle

Group 2 (control): SKIN care bundle


OutcomesPressure ulcer incidence


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "randomly assigned"

Allocation concealment (selection bias)Unclear riskNot stated

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot stated, but difference in the appearance of dressing makes blinding impossible

Blinding of outcome assessment (detection bias)
All outcomes
High riskNot stated

Incomplete outcome data (attrition bias)
All outcomes
High riskEvidence: 367 participants enrolled into the study, analysis conducted on 335 participants

Selective reporting (reporting bias)Unclear riskEvidence: outcome measure was the presence of a pressure ulcer

Comment: this was reported by the authors

Nakagami 2007

MethodsRCT, 3-week follow-up, method of randomisation not stated


Participants37 participants, aged ≥ 65 with a Braden score of < 15, in a 500 bed geriatric hospital in Japan


InterventionsDressing trial

Group 1: PPD (dressing with skin adhesive layer (hydrocolloid), a support layer (urethane film) and an outer layer of multi filament nylon fibres). Applied to either the right or the left trochanter. PPD replaced every week

Group 2: participants acted as their own control, i.e. no dressing was applied to the opposite trochanter


OutcomesIncidence of pressure ulcer

Incidence of persistent erythema


NotesPressure ulcer classification system not clearly described


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNot stated

Allocation concealment (selection bias)Unclear riskNot stated

Blinding of participants and personnel (performance bias)
All outcomes
High riskEvidence for participants: not blinded

Comment: quote: “impossible due to the type of intervention”

Evidence for personnel: not blinded

Comment: quote: “impossible due to the type of intervention”

Blinding of outcome assessment (detection bias)
All outcomes
High riskEvidence for outcomes: not blinded

Comment: quote: "test area outlined so that the dressing applied back to the same area"

Incomplete outcome data (attrition bias)
All outcomes
Low riskITT conducted

Selective reporting (reporting bias)Low riskEvidence: all outcomes reported in the paper were those outlined by the authors

Other biasUnclear riskComment: investigators were part of the group that developed the PPD

Qiuli 2010

MethodsRCT, 7-day follow-up, method of randomisation not stated


Participants52 participants, Waterlow score18-23, in a department of neurosurgery, Harbin, China


InterventionsIntervention: mepilex dressing applied to weight-bearing bony areas

Control: massage of bony areas

Both groups turned 2-3 hourly and nursed on air cushion beds


OutcomesIncidence of pressure ulcer


NotesPressure ulcer classification system not described


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNot stated

Allocation concealment (selection bias)Unclear riskNot stated

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot stated, but difference in the appearance of dressing makes blinding impossible

Blinding of outcome assessment (detection bias)
All outcomes
High riskNot stated

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskAll participants included in the final analysis

Selective reporting (reporting bias)Low riskEvidence: all outcomes reported in the paper were those outlined by the authors

Smith 1985

MethodsDouble-blind RCT, 24-week follow-up, method of randomisation not stated


Participants258 elderly continuing-care patients, UK


InterventionsTopical agent trial

Group 1 (intervention): Conotrane (silicone cream; 20% dimethicone 350; and a broad spectrum antiseptic (0.05% hydrargaphen)), skin washed, dried and ointment applied

Group 2 (control): Unguentum cream, skin washed, dried and ointment applied


OutcomesPressure ulcer incidence


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNot stated

Allocation concealment (selection bias)Unclear riskNot stated

Blinding of participants and personnel (performance bias)
All outcomes
Low riskEvidence for participants: no mention within the article

Comment: quote: The placebo ointment had been suitably scented so that it was indistinguishable from the active preparation

Evidence for personnel: no mention within the article

Comment: quote: "The placebo ointment had been suitably scented so that it was indistinguishable from the active preparation"

Blinding of outcome assessment (detection bias)
All outcomes
Low riskEvidence for outcomes: no mention within the article

Comment: quote: "The placebo ointment had been suitably scented so that it was indistinguishable from the active preparation"

Incomplete outcome data (attrition bias)
All outcomes
Low riskEvidence: results table 1: of 258 participants

Comment: data presented related to those who entered the study

Selective reporting (reporting bias)Low riskEvidence: all outcomes reported in the paper were those outlined by the authors

Other biasUnclear riskComment: one third more participants in the placebo group were incontinent of urine and one quarter more were incontinent of faeces when compared with the treatment group

Torra i Bou 2005

MethodsMulticentre double-blind RCT, randomised code in a closed envelope, 30-day follow-up


Participants380 individuals at risk of pressure ulcers, in Spain


InterventionsTopical agent trial

Group 1 (intervention): Mepentol, a hyperoxygenated fatty acid compound (consisting of: oleic acid, palmitic acid, stearic acid, palmitoleic acid, linoleic acid, gamma-linoleic acid, arachidonic acid, and eicosenoic acid), applied twice daily to at least 3 areas of the body, sacrum, trochanter, heels

Group 2 (control): compound consisting of trisostearin (99.4%) and perfume (0.6%) applied twice daily to at least 3 areas of the body, sacrum, trochanter, heels


OutcomesPressure ulcer incidence

Cost


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskComment: did not state how the randomisation sequence was generated

Allocation concealment (selection bias)Unclear riskEvidence: coded randomisation in closed envelope

Comment: did not state that the envelopes were opaque

Blinding of participants and personnel (performance bias)
All outcomes
Low riskEvidence for participants: blinded

Comment: quote: "only the coordinator had access to the packaging codes so neither the investigator nor patient knew which group a patient had been allocated to"

Evidence for personnel: blinded

Comment: quote: "only the coordinator had access to the packaging codes so neither the investigator nor patient knew which group a patient had been allocated to"

Blinding of outcome assessment (detection bias)
All outcomes
Low riskEvidence for outcomes: blinded

Comment: quote: "only the coordinator had access to the packaging codes so neither the investigator nor patient knew which group a patient had been allocated to"

Incomplete outcome data (attrition bias)
All outcomes
High riskEvidence: ITT not conducted, results presented for 167 and 164 participants and not for the original 380 enrolled

Selective reporting (reporting bias)Low riskEvidence: all outcomes reported in the paper were those outlined by the authors

Other biasLow risk

Van Der Cammen 1987

MethodsDouble-blind RCT, method of randomisation not stated


Participants120 chair-bound participants, with a Norton score 5-14, from the Department of Geriatric Medicine, UK


InterventionsTopical agent trial

Group 1 (intervention): buttocks and sacral areas washed and dried, and Prevasore (Hexyl nicotinate, zinc stearate, isopropyl myristate, Dimethicone 350, cetrimide and glycol) applied at least twice daily, and after changing, if wet or soiled

Group 2 (control): buttocks and sacral areas washed and dried, and Dermalex (hexachlorophane, squalene and allantoin) applied at least twice daily, and after changing, if wet or soiled


OutcomesPressure ulcer incidence


NotesData presented for 104 participants


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNot stated

Allocation concealment (selection bias)Unclear riskNot stated

Blinding of participants and personnel (performance bias)
All outcomes
Low riskEvidence for participants: Quote " . . . this formulation was compared, in a double blind clinical trial . . "

Evidence for personnel: Quote " . . . this formulation was compared, in a double blind clinical trial . . . "

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskEvidence for outcomes: not mentioned

Comment: although unclear, it is probable that outcome assessment was blinded, given that the trial was 'double blinded'

Incomplete outcome data (attrition bias)
All outcomes
High riskEvidence: ITT not conducted

Comment: Data presented relate to the number who concluded the study excluding those withdrawn

Selective reporting (reporting bias)Low riskEvidence: All outcomes reported in the paper are those outlined by the authors

Other biasUnclear riskComment: Corresponding author member of staff of the manufacturer of the product under investigation

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Callaghan 1998Not an RCT

Declaire 1997Not an RCT

Duimel-Peeters 2007Cross-over trial

Garcia Fernandez 2005Review of a previous study by Torra i Bou

Hsu 2011Quasi-experimental

Huang 2009Not an RCT

Kuisma 1987Treatment intervention not prevention

Smith 2010Not an RCT

Stoker 1990Treatment intervention not prevention

Torra i Bou 2009Cost analysis from an unpublished study, presented at a Pressure Ulcer Advisory Panel meeting in 2002. No abstract available.

 
Comparison 1. Topical agent versus placebo

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Pressure ulcer incidence4Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 
Comparison 2. Topical agent versus control (Houwing)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Pressure ulcer incidence147Risk Ratio (M-H, Fixed, 95% CI)1.60 [0.84, 3.04]

 
Comparison 3. Placebo versus control (Houwing)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Pressure ulcer incidence150Risk Ratio (M-H, Fixed, 95% CI)0.80 [0.37, 1.74]

 
Comparison 4. Topical agent versus placebo (Houwing)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Pressure ulcer incidence161Risk Ratio (M-H, Fixed, 95% CI)1.99 [1.10, 3.57]

 
Comparison 5. Topical agent versus placebo combined studies

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Pressure ulcer incidence5940Risk Ratio (M-H, Random, 95% CI)0.78 [0.47, 1.31]

 2 Pressure ulcer incidence4879Risk Ratio (M-H, Fixed, 95% CI)0.64 [0.49, 0.83]

 
Comparison 6. Dressing versus no dressing

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Pressure ulcer incidence4Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 
Comparison 7. Dressing versus no dressing combined studies

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Pressure ulcer incidence4561Risk Ratio (M-H, Fixed, 95% CI)0.21 [0.09, 0.51]

 
Summary of findings for the main comparison. Topical agent compared with placebo for preventing pressure ulcers

Topical agent versus placebo combined studies for preventing pressure ulcers

Patient or population: Patients at risk of developing pressure ulcers
Settings: Hospitals
Intervention: Topical agent versus placebo

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

ControlTopical agent versus placebo

Pressure ulcer incidence
Observation
Follow-up: 3 to 24 weeks
Study populationRR 0.78
(0.47 to 1.31)
940
(5 studies)
⊕⊝⊝⊝
very low1,2,3,4

251 per 1000195 per 1000
(118 to 328)

Moderate

313 per 1000244 per 1000
(147 to 410)

*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; RR: Risk ratio

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

 1 Limited information provided for generation of allocation sequence, allocation concealment and outcome evaluation. Three of the five trials had incomplete reporting and the majority received manufacturer sponsorship
2 There were variations in both the intervention products and the control products. Different measures (some unvalidated) were used to assess the stage of the pressure ulcer
3 Most of the participants were geriatric patients in hospitals and nursing homes. Other groups at high risk (such as those unable to reposition and intensive care patients) were not represented
4 Confidence intervals were wide due to small sample sizes
 
Summary of findings 2. Dressing compared with no dressing combined studies for preventing pressure ulcers

Dressing versus no dressing combined studies for preventing pressure ulcers

Patient or population: Patients at risk of developing pressure ulcers
Settings: Hospital
Intervention: Dressing versus no dressing

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

ControlDressing versus no dressing combined studies

Pressure ulcer incidence
Observation
Follow-up: > 48 h to 3 weeks
Study populationRR 0.21
(0.09 to 0.51)
561
(4 studies)
⊕⊕⊝⊝

low1,2,3,4

93 per 100019 per 1000
(8 to 47)

Moderate

107 per 100022 per 1000
(10 to 55)

*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; RR: Risk ratio

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

 1 There was no description of sequence generation or allocation concealment in any of the trials. Intervention blinding was not possible. Outcome assessment was not blinded in two studies and unclear in the remaining two trials. Three of the four trials received manufacturer support
2 Although heterogeneity was low, three types of dressings were used, the composition of each was quite different
3 Participants in all of the trials were at very high risk of pressure ulcer development (drawn from intensive care/cardiac care units or geriatric units), so results may not be generalisable to all hospitalised patients
4 Three of the four trials were small, with fewer than 100 participants. This resulted in wide confidence intervals around the effect size, creating uncertainty around the precision of the result.
 
Table 1. Intervention topical agents and dressings

AUTHOR YEAR TOPICAL AGENTS DRESSINGS

Green 1974Dermalex™: consisting of hexachlorophane 0.5%, squalene (Cosbiol 3%), and allantoin 0.2%, lanolin, fatty acids, fatty alcohols, and antioxidants 

Han 2011 Kang’ huier transparent strip and foam dressing

Houwing 2008DMSO-cream: consisting of 5% dimethyl sulfoxide in Vaseline-cetomacrogol cream 

Kalowes 2012Soft silicone, self adherent, bordered foam dressing

Nakagami 2007 REMOIS PAD (designed to reduce shear forces with a low friction outer layer and containing a ceramide supplementation to improve the water-holding capacity of the skin. Ceramide is composed of sphingosine and a fatty acid)

Qiuli 2010Soft silicone, self adherent, bordered foam dressing

Smith 1985Conotrane: consisting of a silicone cream, 20% dimethicone 350, and a broad spectrum antiseptic (0.05% hydrargaphen) 

Torra i Bou 2005Mepentol: a hyperoxygenated fatty acid compound consisting of oleic acid, palmitic acid, stearic acid, palmitoleic acid, linoleic acid, gamma linoleic acid, arachidonic acid, and eicosenoic acid  

Van Der Cammen 1987Prevasore: consisting of hexyl nicotinate, zinc stearate, isopropyl myristate, Dimethicone 350, cetrimide and glycol