This is not the most recent version of the article. View current version (22 APR 2015)

Intervention Review

You have free access to this content

Use of plastic adhesive drapes during surgery for preventing surgical site infection

  1. Joan Webster1,2,3,*,
  2. Abdullah Alghamdi4

Editorial Group: Cochrane Wounds Group

Published Online: 31 JAN 2013

Assessed as up-to-date: 25 JUL 2012

DOI: 10.1002/14651858.CD006353.pub3


How to Cite

Webster J, Alghamdi A. Use of plastic adhesive drapes during surgery for preventing surgical site infection. Cochrane Database of Systematic Reviews 2013, Issue 1. Art. No.: CD006353. DOI: 10.1002/14651858.CD006353.pub3.

Author Information

  1. 1

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

  2. 2

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

  3. 3

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

  4. 4

    St Michael's Hospital, University of Toronto, Department of Surgery, Toronto, ON, Canada

*Joan Webster, Centre for Clinical Nursing, Royal Brisbane and Women's Hospital, Level 2, Building 34, Butterfield Street, Brisbane, Queensland, 4029, Australia. joan_webster@health.qld.gov.au. wigan1943@bigpond.com.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 31 JAN 2013

SEARCH

This is not the most recent version of the article. View current version (22 APR 2015)

 
Characteristics of included studies [ordered by study ID]
Chiu 1993

MethodsStudy type: single-centre RCT
Follow-up period: 6 months


ParticipantsPeople undergoing acute hip fracture surgery


InterventionsOpsite (Smith & Nephew) adhesive plastic incisional drapes compared with no incisional drapes


OutcomesSurgical wound infection (reported as deep and superficial infection). No definition of infection provided
Bacterial colonisation


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskMethod not described

Allocation concealment (selection bias)Unclear riskMethod not described

Blinding (performance bias and detection bias)
All outcomes
High riskMasking was impossible for surgeons
It is unclear if patients were aware of their group allocation
Whether outcome assessors were masked is unclear. The author states "After the operation, the wound was observed for clinical infection" but there was no indication of who undertook this assessment nor if those assessing the outcome were aware of the group allocation

Incomplete outcome data (attrition bias)
All outcomes
Low riskThe authors state that 120 patients were enrolled and results were available for all of these patients. No mention of intention-to-treat analysis was made

Selective reporting (reporting bias)Low riskResults for all expected outcomes were reported

Other biasLow riskNo competing interests were declared. Although no data were shown, the authors stated that patients were matched for relevant risk factors at baseline

Cordtz 1989

MethodsStudy type: multi-centre RCT
Follow-up period: 14 days


ParticipantsWomen undergoing caesarean section. Includes infected and possibly infected cases


InterventionsAdhesive plastic incisional drapes compared with no adhesive plastic incisional drapes


OutcomesSurgical wound infection (defined as possibly infected if there was localised erythema and/or serous secretion without the presence of pus)


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandom allocation, using block design, in blocks of eight

Allocation concealment (selection bias)Unclear riskNot described. However, the study, which included eight hospitals, was carried out under the supervision of the Danish National Centre for Hospital Hygiene, so it is likely that an appropriate method of allocation concealment was used

Blinding (performance bias and detection bias)
All outcomes
High riskMasking was impossible for surgeons
It is unclear if patients were aware of their group allocation
Whether outcome assessors were masked is unclear. The author states "Post-operative observations of the wounds were continued in hospital until the fourteenth post-operative day" but there was no indication of who undertook this assessment nor if the assessors were aware of the group allocation

Incomplete outcome data (attrition bias)
All outcomes
Low risk64 patients were excluded before randomisation but details by group were not provided. No mention of intention-to-treat analysis was made

Selective reporting (reporting bias)Low riskResults for all expected outcomes were reported

Other biasLow riskNo competing interests declared. No baseline data reported

Dewan 1987

MethodsStudy type: single-centre RCT
Follow-up period: 3 weeks


ParticipantsPeople undergoing general surgery


InterventionsIoban (3M Company) iodine-impregnated adhesive plastic incisional drapes compared with no incisional drapes


OutcomesSurgical wound infection (defined as a wound that discharged pus or if the fluid discharging from the wound was associated with a positive bacterial culture or if erythema was present more than 1cm lateral to the wound)
Death
Bacterial colonisation


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandom number table

Allocation concealment (selection bias)Low riskSurgeons sequentially selected the allocation from the random numbers table located in the operating room Consequently, surgeons would have been aware of the next allocation

Blinding (performance bias and detection bias)
All outcomes
High riskMasking was impossible for surgeons
It is unclear if patients were aware of their group allocation
Outcome assessment was masked "Postoperatively, wound follow-up was carried out by the infection control nurse who was unaware whether the drape had been used or not"

Incomplete outcome data (attrition bias)
All outcomes
Low risk86 (7.8%) patients were excluded after randomisation (40 for incomplete records and 46 because they were unable to be followed up for the three-week period considered necessary). These were not displayed by group

Selective reporting (reporting bias)Low riskResults for all expected outcomes were reported

Other biasLow riskNo competing interests declared. Patients equally distributed for all major risk factors for surgical site infection

Jackson 1971

MethodsStudy type: single-centre RCT
Follow-up period: 1 month


ParticipantsPeople undergoing general surgery


InterventionsAdhesive plastic incisional drapes (Band-aid) compared with no adhesive plastic incisional drapes


OutcomesSurgical wound infection (defined as a wound discharging pus and included stitch abscess)


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskSpin of a coin

Allocation concealment (selection bias)Low riskThe coin was 'spun' at the beginning of the operation. Allocation would have been concealed until then and the next allocation would be unpredictable

Blinding (performance bias and detection bias)
All outcomes
High riskMasking was impossible for surgeons
It is unclear if patients were aware of their group allocation
Two of the authors, who were also surgeons involved in the trial, followed up all patients until one month after the surgery to record any wound infection

Incomplete outcome data (attrition bias)
All outcomes
Low riskFollow-up data was reported on all enrolled participants

Selective reporting (reporting bias)Low riskResults for all expected outcomes were reported

Other biasUnclear riskThe investigators "concurrently ran a test of an antibiotic spray in random cases." Results were to be reported separately. It is unclear if the spray was used equally between groups
No baseline data were reported. No competing interests reported

Psaila 1977

MethodsStudy type: Single-centre RCT
Follow-up period: Not defined


ParticipantsPeople undergoing abdominal surgery


InterventionsAdhesive plastic incisional drapes compared with no adhesive plastic incisional drapes and a ring drape


OutcomesSurgical wound infection (defined as erythema around sutures or wound edge with an accompanying pyrexia;
discharge or exudate from the wound; wound breakdown)
Bacterial colonisation


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskMethod not described

Allocation concealment (selection bias)Unclear riskMethod not described

Blinding (performance bias and detection bias)
All outcomes
High riskMasking was impossible for surgeons
It is unclear if patients were aware of their group allocation
Wounds were inspected daily after the third day to identify evidence of infection but it is not clear who did this; nor if the assessors were aware of the patients allocation status

Incomplete outcome data (attrition bias)
All outcomes
Low riskAll enrolled patients were accounted for in the results

Selective reporting (reporting bias)Low riskResults for all expected outcomes were reported

Other biasUnclear riskNo baseline data were reported. No competing interests reported

Segal 2002

MethodsStudy type: single-centre RCT
Follow-up period: 6 weeks


ParticipantsPeople at high risk undergoing cardiac surgery


InterventionsIodine-impregnated adhesive plastic incisional drapes compared with no incisional drapes


OutcomesSurgical wound infection. No clear definition of infection but included drainage, redness, tenderness or instability


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskPieces of paper marked with equal numbers of the different allocations were placed in a sack

Allocation concealment (selection bias)Low riskWhen an eligible patient was identified, a piece of paper containing the allocation was drawn out of the sack by the operating room Charge Nurse

Blinding (performance bias and detection bias)
All outcomes
High riskMasking was impossible for surgeons
It is unclear if patients were aware of their group allocation
The person assessing the outcome was aware of the patient's allocation group

Incomplete outcome data (attrition bias)
All outcomes
Low riskAll enrolled patients were followed up

Selective reporting (reporting bias)Low riskResults for all expected outcomes were reported

Other biasLow riskPatients equal at baseline for risk factors (communication with authors). No competing interests

Ward 2001

MethodsStudy type: single-centre RCT
Follow-up period: 5 days


ParticipantsWomen undergoing caesarean section


InterventionsIncise (Smith & Nephew) adhesive plastic incisional drapes compared with no adhesive plastic incisional drapes


OutcomesSurgical wound infection (defined as having to include 2 of the following: erythema around sutures or wound edge; seropurulent discharge from the wound; positive swab culture)
Number of days in hospital


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandom number table

Allocation concealment (selection bias)Low riskAllocation contained in opaque unmarked envelope

Blinding (performance bias and detection bias)
All outcomes
Low riskMasking was impossible for surgeons
Patients were blind to their allocation as the drape was placed after anaesthetic induction
Outcome assessment was blinded, postoperative care was provided by staff unrelated to surgery

Incomplete outcome data (attrition bias)
All outcomes
Low riskOf the 620 patients randomised, 15 (2.4%) had critical data missing from their records and a further two patients were excluded, one for an existing infection and one for early discharge

Selective reporting (reporting bias)Low riskResults for all expected outcomes were reported

Other biasUnclear riskPatients were only followed up for 5 days; some infections would have occurred after this time. Baseline risk factors were equally distributed between groups

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Breitner 1986Not a RCT

Duvvi 2005Not a RCT

Fairclough 1986Not a RCT

French 1976Did not report wound infection rate

Ha'eri 1983Did not report wound infection rate

Lewis 1984Number of participants in each treatment arm not reported

Manncke 1984Did not report wound infection rate

Maxwell 1969Not a RCT

Nystrom 1980Plastic incisional drape not used

Nystrom 1984Plastic incisional drape not used

Swenson 2008Not a RCT

Williams 1972Plastic incisional drape not used

Yoshimura 2003Not a RCT

 
Comparison 1. Adhesive drapes versus no adhesive drapes

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

 1 Surgical site infection (all wound classifications)53082Risk Ratio (M-H, Fixed, 95% CI)1.23 [1.02, 1.48]

 2 Surgical site infection (by wound classification)1921Risk Ratio (M-H, Fixed, 95% CI)1.20 [0.86, 1.66]

    2.1 Clean
1363Risk Ratio (M-H, Fixed, 95% CI)1.37 [0.53, 3.53]

    2.2 Potentially infected
1486Risk Ratio (M-H, Fixed, 95% CI)1.24 [0.80, 1.92]

    2.3 Infected
172Risk Ratio (M-H, Fixed, 95% CI)1.03 [0.60, 1.75]

 3 Length of hospital stay1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    3.1 Infected wound
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    3.2 No infected wound
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 2. Iodine-impregnated adhesive drapes versus no adhesive drapes

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

 1 Surgical site infection21113Risk Ratio (M-H, Fixed, 95% CI)1.03 [0.66, 1.60]

 
Summary of findings for the main comparison.

Adhesive drapes compared with no adhesive drapes for preventing surgical site infection

Patient or population: Patients undergoing surgery
Settings: Hospital
Intervention: Adhesive drapes

Comparison: No adhesive drapes

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

Assumed riskCorresponding risk

ControlAdhesive drapes versus no adhesive drapes

Surgical site infection (all wound classifications)
Inspection of the wound1
(follow-up: 5 to 24 weeks2)
Medium risk populationRR 1.23
(1.02 to 1.48)
3082
(5)
⊕⊕⊕⊕
High3,4

109 per 1000134 per 1000
(111 to 161)

*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% CI) 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 Various definitions of infection were used; we accepted the authors definition in each case.
2 In one trial (Psaila 1977) the follow-up period was not nominated.
3 Generation of random allocation sequence was unclear in two trials (Chiu 1993; Psaila 1977). Allocation concealment was unclear in four trials (Chiu 1993; Cordtz 1989; Jackson 1971; Psaila 1977). Outcome assessment was blinded in only one of the five studies (Ward 2001). However, although information about these quality issues were not available for some trials, results were similar across trials so we do not believe results were compromised by these omissions in reporting.
4 The total sample met requirements for optimal information size, and the total number of events exceeded 300.
 
Summary of findings 2.

Iodophore-impregnated adhesive drapes compared with no adhesive drapes for preventing surgical site infection

Patient or population: Patients undergoing surgery
Settings: Hospital
Intervention: Iodophore-impregnated adhesive drapes
Comparison: No adhesive drapes

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

Assumed riskCorresponding risk

No adhesive drapesIodophore-impregnated adhesive drapes

Surgical site infection
Inspection of the wound1
(follow-up: 3 to 6 weeks)
Medium risk populationRR 1.03
(0.66 to 1.6)
1113
(2)
⊕⊕⊕⊝
Moderate2,3

45 per 100046 per 1000
(30 to 72)

*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% CI) 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 A number of definitions of wound infection were used across the trials. We accepted the authors definition in all cases.
2 Although information about allocation concealment was unclear in one trial (Dewan 1987) and outcome assessment was not blinded in the Segal 2002 trial, we have judged that this has not compromised the result.
3 There was imprecision on at least two counts; the total sample size was too small to meet optimal information size, and the total number of events was less than 300.