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Uso de paños adhesivos plásticos durante la cirugía para la prevención de la infección del sitio quirúrgico

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Referencias

References to studies included in this review

Chiu 1993 {published data only}

Chiu KY, Lau SK, Fung B, Ng KH, Chow SP. Plastic adhesive drapes and wound infection after hip fracture surgery. Australian and New Zealand Journal of Surgery 1993;63:798‐801. CENTRAL

Cordtz 1989 {published data only}

Cordtz T, Schouenborg L, Laursen K, Daugaard HO, Buur K, Munk Christensen B, et al. The effect of incisional plastic drapes and redisinfection of operation site on wound infection following caesarean section. Journal of Hospital infection 1989;13(3):267‐72. CENTRAL

Dewan 1987 {published data only}

Dewan PA, Van Rij AM, Robinson RG, Skeggs GB, Fergus M. The use of an iodophor‐impregnated plastic incise drape in abdominal surgery ‐ a controlled clinical trial. Australian and New Zealand Journal of Surgery 1987;57(11):859‐63. CENTRAL

Jackson 1971 {published data only}

Jackson DW, Pollock AV, Tindal DS. The value of a plastic adhesive drape in the prevention of wound infection. A controlled trial. British Journal of Surgery 1971;58(5):340‐2. CENTRAL

Psaila 1977 {published data only}

Psaila JV, Wheeler MH, Crosby DL. The role of plastic wound drapes in the prevention of wound infection following abdominal surgery. British Journal of Surgery 1977;64(10):729‐32. CENTRAL

Segal 2002 {published data only}

Segal CG, Anderson JJ. Preoperative skin preparation of cardiac patients. AORN Journal 2002;76(5):821‐8. CENTRAL

Ward 2001 {published data only}

Ward HR, Jennings OG, Potgieter P, Lombard CJ, Ward HR, Jennings OG, et al. Do plastic adhesive drapes prevent post caesarean wound infection?. Journal of Hospital Infection 2001;47(3):230‐4. CENTRAL

References to studies excluded from this review

Breitner 1986 {published data only}

Breitner S, Ruckdeschel G. Bacteriologic studies of the use of incision drapes in orthopedic operations. Unfallchirurgie 1986;12(6):301‐4. CENTRAL

Duvvi 2005 {published data only}

Duvvi SK, Lo S, Spraggs PD. A plastic drape in nasal surgery. Plastic and Reconstive Surgery 2005;116(7):2041‐2. CENTRAL

Fairclough 1986 {published data only}

Fairclough JA, Johnson D, Mackie I. The prevention of wound contamination by skin organisms by the pre‐operative application of an iodophor impregnated plastic adhesive drape. Journal of International Medical Research 1986;14(2):105‐9. CENTRAL

Falk‐Brynhildsen 2013a {published data only}

Falk‐Brynhildsen K, Friberg O, Söderquist B, Nilsson UG. Bacterial recolonization of the skin and wound contamination during cardiac surgery: a randomized controlled trial of the use of plastic adhesive drapes compared with bare skin. Journal of Hospital Infection 2013;84:151‐158. CENTRAL

French 1976 {published data only}

French ML, Eitzen HE, Ritter MA. The plastic surgical adhesive drape: an evaluation of its efficacy as a microbial barrier. Annals of Surgery 1976;184(1):46‐50. CENTRAL

Ha'eri 1983 {published data only}

Ha'eri GB. The efficacy of adhesive plastic incise drapes in preventing wound contamination. International Surgery 1983;68(1):31‐2. CENTRAL

Lewis 1984 {published data only}

Lewis DA, Leaper DJ, Speller DC. Prevention of bacterial colonization of wounds at operation: comparison of iodine‐impregnated ('Ioban') drapes with conventional methods. Journal of Hospital Infection 1984;5(4):431‐7. CENTRAL

Manncke 1984 {published data only}

Manncke M, Heeg P. Experimental and clinical studies of the efficacy of an antimicrobial incision drape. Der Chirurg; Zeitschrift für alle Gebiete der operativen Medizen 1984;55(8):515‐8. CENTRAL

Maxwell 1969 {published data only}

Maxwell JG, Ford CR, Peterson DE, Richards RC. Abdominal wound infections and plastic drape protectors. American Journal of Surgery 1969;116(6):844‐8. CENTRAL

Nystrom 1980 {published data only}

Nystrom PO, Brote L. Effects of a plastic wound drape on contamination with enterobacteria and on infection after appendicectomy. Acta Chirurgica Scandinavica 1980;146(1):67‐70. CENTRAL

Nystrom 1984 {published data only}

Nystrom PO, Broome A, Hojer H, Ling L. A controlled trial of a plastic wound ring drape to prevent contamination and infection in colorectal surgery. Diseases of the Colon and Rectum 1984;27:451‐3. CENTRAL

Swenson 2008 {published data only}

Swenson BR, Camp TR, Mulloy DP, Sawyer RG. Antimicrobial‐impregnated surgical incise drapes in the prevention of mesh infection after ventral hernia repair. Surgical infections 2008;9(1):23‐32. CENTRAL

Williams 1972 {published data only}

Williams JA, Oates GD, Brown PP, Burden DW, McCall J, Hutchison AG, et al. Abdominal wound infections and plastic wound guards. British Journal of Surgery 1972;59(2):142‐6. CENTRAL

Yoshimura 2003 {published data only}

Yoshimura Y, Kubo S, Hirohashi K, Ogawa M, Morimoto K, Shirata K, et al. Plastic iodophor drape during liver surgery operative use of the iodophor‐impregnated adhesive drape to prevent wound infection during high risk surgery. World Journal of Surgery 2003;27(6):685‐8. CENTRAL

Additional references

Alexander 2011

Alexander JW, Solomkin JS, Edwards MJ. Updated recommendations for control of surgical site infections. Annals of Surgery 2011;253:1083‐93.

Bruce 2001

Bruce J, Russell EM, Mollinson J, Krukowski ZH. The measurement and monitoring of surgical adverse events. Health Technology Assessment 2001;5:1‐194.

Coello 2005

Coello R, Charlett A, Wilson J, Ward V, Pearson A, Borriello P. Adverse impact of surgical site infections in English hospitals. Journal of Hospital Infection 2005;60:93‐103.

Edwards 2009

Edwards PS, Lipp A, Holmes A. Preoperative skin antiseptics for preventing surgical wound infections after clean surgery. Cochrane Database of Systematic Reviews 2009, Issue 3. [DOI: 10.1002/14651858.CD003949.pub2]

Falk‐Brynhildsen 2013

Falk‐Brynhildsen K, Friberg O, Söderquist B, Nilsson UG. Bacterial colonization of the skin following aseptic preoperative preparation and impact of the use of plastic adhesive drapes. Biological Research for Nursing2013; Vol. 15:242‐248. [DOI: 10.1177/1099800411430381]

Fleischmann 1996

Fleischmann W, Meyer H, von Baer A. Bacterial recolonization of the skin under a polyurethane drape in hip surgery. Journal of Hospital Infection 1996;34(2):107‐16.

Gaynes 2001

Gaynes RP, Culver DH, Horan TC, Edwards JR, Richards C, Tolson JS. Surgical site infection (SSI) rates in the United States, 1992‐1998: the National Nosocomial Infections Surveillance System basic SSI risk index. Clinical Infectious Diseases 2001;33(Suppl 2):S69‐77.

Higgins 2002

Higgins JPT, Thompson SG. Quantifying heterogeneity in a meta‐analysis. Statistics in Medicine 2002;21:539‐58.

Higgins 2011

Higgins JPT, Altman DG, Sterne JAC (editors). Chapter 8. Assessing risk of bias in included studies. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org.

Kashimura 2012

Kashimura N, Kusachi S, Konishi T, Shimizu J, Kusunoki M, Oka M, et al. Impact of surgical site infection after colorectal surgery on hospital stay and medical expenditure in Japan. Surgery Today 2012 Jan 31 [Epub ahead of print].

Katthagen 1992

Katthagen BD, Zamani P, Jung W. Effect of surgical draping on bacterial contamination in the surgical field. Zeitschrift für Orthopädie und ihre Grenzgebiete 1992;130:230‐5.

Lefebvre 2011

Lefebvre C, Manheimer E, Glanville J. Chapter 6: Searching for studies. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org.

Lilani 2005

Lilani SP, Jangale N, Chowdhary A, Daver GB. Surgical site infection in clean and clean‐contaminated cases. Indian Journal of Medical Microbiology 2005;23:249‐52.

Lilly 1970

Lilly HA, Lowbury EJ, London PS, Porter MF. Effects of adhesive drapes on contamination of operation wounds. Lancet 1970;7670:431‐2.

Mangram 1999

Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guidelines for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infection Control and Hospital Epidemiology 1999;20:250‐78.

Nichols 1996

Nichols RN. Surgical infections: prevention and treatment ‐1965 to 1995. American Journal of Surgery 1996;172(1):68‐74.

Payne 1956

Payne JT. An adhesive surgical drape. American Journal of Surgery 1956;91:110‐12.

RevMan 2011 [Computer program]

The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 5.1. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2011.

Ritter 1988

Ritter MA, Campbell ED. Retrospective evaluation of an iodophor‐incorporated antimicrobial plastic adhesive wound drape. Clinical Orthopaedics and Related Research 1988;228:307‐8.

SIGN 2012

Scottish Intercollegiate Guidelines Network (SIGN). Search filters. www.sign.ac.uk/methodology/filters.html#random (Accessed 10 August 2012).

Smyth 2000

Smyth ET, Emmerson AM. Surgical site infection surveillance. Journal of Hospital Infection 2000;45:173‐84.

Thompson 2011

Thompson KM, Oldenburg WA, Deschamps C, Rupp WC, Smith CD. Chasing zero: the drive to eliminate surgical site infections. Annals of Surgery 2011;254(3):430‐6.

Zokaie 2011

Zokaie S, White IR, McFadden JD. Allergic contact dermatitis caused by iodophor‐impregnated surgical incise drape. Contact Dermatitis 2011;65(5):309.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Chiu 1993

Methods

Study type: single‐centre RCT
Follow‐up period: 6 months

Participants

People undergoing acute hip fracture surgery

Interventions

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

Outcomes

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

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Method not described

Allocation concealment (selection bias)

Unclear risk

Method not described

Blinding (performance bias and detection bias)
All outcomes

High risk

Masking 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 risk

The 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 risk

Results for all expected outcomes were reported

Other bias

Low risk

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

Cordtz 1989

Methods

Study type: multi‐centre RCT
Follow‐up period: 14 days

Participants

Women undergoing caesarean section. Includes infected and possibly infected cases

Interventions

Adhesive plastic incisional drapes compared with no adhesive plastic incisional drapes

Outcomes

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

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random allocation, using block design, in blocks of eight

Allocation concealment (selection bias)

Unclear risk

Not 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 risk

Masking 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 risk

64 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 risk

Results for all expected outcomes were reported

Other bias

Low risk

No competing interests declared. No baseline data reported

Dewan 1987

Methods

Study type: single‐centre RCT
Follow‐up period: 3 weeks

Participants

People undergoing general surgery

Interventions

Ioban (3M Company) iodine‐impregnated adhesive plastic incisional drapes compared with no incisional drapes

Outcomes

Surgical 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

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random number table

Allocation concealment (selection bias)

Low risk

Surgeons 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 risk

Masking 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 risk

86 (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 risk

Results for all expected outcomes were reported

Other bias

Low risk

No competing interests declared. Patients equally distributed for all major risk factors for surgical site infection

Jackson 1971

Methods

Study type: single‐centre RCT
Follow‐up period: 1 month

Participants

People undergoing general surgery

Interventions

Adhesive plastic incisional drapes (Band‐aid) compared with no adhesive plastic incisional drapes

Outcomes

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

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Spin of a coin

Allocation concealment (selection bias)

Low risk

The 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 risk

Masking 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 risk

Follow‐up data was reported on all enrolled participants

Selective reporting (reporting bias)

Low risk

Results for all expected outcomes were reported

Other bias

Unclear risk

The 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

Methods

Study type: Single‐centre RCT
Follow‐up period: Not defined

Participants

People undergoing abdominal surgery

Interventions

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

Outcomes

Surgical 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

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Method not described

Allocation concealment (selection bias)

Unclear risk

Method not described

Blinding (performance bias and detection bias)
All outcomes

High risk

Masking 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 risk

All enrolled patients were accounted for in the results

Selective reporting (reporting bias)

Low risk

Results for all expected outcomes were reported

Other bias

Unclear risk

No baseline data were reported. No competing interests reported

Segal 2002

Methods

Study type: single‐centre RCT
Follow‐up period: 6 weeks

Participants

People at high risk undergoing cardiac surgery

Interventions

Iodine‐impregnated adhesive plastic incisional drapes compared with no incisional drapes

Outcomes

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

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Pieces of paper marked with equal numbers of the different allocations were placed in a sack

Allocation concealment (selection bias)

Low risk

When 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 risk

Masking 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 risk

All enrolled patients were followed up

Selective reporting (reporting bias)

Low risk

Results for all expected outcomes were reported

Other bias

Low risk

Patients equal at baseline for risk factors (communication with authors). No competing interests

Ward 2001

Methods

Study type: single‐centre RCT
Follow‐up period: 5 days

Participants

Women undergoing caesarean section

Interventions

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

Outcomes

Surgical 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

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random number table

Allocation concealment (selection bias)

Low risk

Allocation contained in opaque unmarked envelope

Blinding (performance bias and detection bias)
All outcomes

Low risk

Masking 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 risk

Of 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 risk

Results for all expected outcomes were reported

Other bias

Unclear risk

Patients 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]

Study

Reason for exclusion

Breitner 1986

Not a RCT

Duvvi 2005

Not a RCT

Fairclough 1986

Not a RCT

Falk‐Brynhildsen 2013a

Did not report wound infection rate

French 1976

Did not report wound infection rate

Ha'eri 1983

Did not report wound infection rate

Lewis 1984

Number of participants in each treatment arm not reported

Manncke 1984

Did not report wound infection rate

Maxwell 1969

Not a RCT

Nystrom 1980

Plastic incisional drape not used

Nystrom 1984

Plastic incisional drape not used

Swenson 2008

Not a RCT

Williams 1972

Plastic incisional drape not used

Yoshimura 2003

Not a RCT

RCT: randomised controlled trial

Data and analyses

Open in table viewer
Comparison 1. Adhesive drapes versus no adhesive drapes

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Surgical site infection (all wound classifications) Show forest plot

5

3082

Risk Ratio (M‐H, Fixed, 95% CI)

1.23 [1.02, 1.48]

Analysis 1.1

Comparison 1 Adhesive drapes versus no adhesive drapes, Outcome 1 Surgical site infection (all wound classifications).

Comparison 1 Adhesive drapes versus no adhesive drapes, Outcome 1 Surgical site infection (all wound classifications).

2 Surgical site infection (by wound classification) Show forest plot

1

921

Risk Ratio (M‐H, Fixed, 95% CI)

1.20 [0.86, 1.66]

Analysis 1.2

Comparison 1 Adhesive drapes versus no adhesive drapes, Outcome 2 Surgical site infection (by wound classification).

Comparison 1 Adhesive drapes versus no adhesive drapes, Outcome 2 Surgical site infection (by wound classification).

2.1 Clean

1

363

Risk Ratio (M‐H, Fixed, 95% CI)

1.37 [0.53, 3.53]

2.2 Potentially infected

1

486

Risk Ratio (M‐H, Fixed, 95% CI)

1.24 [0.80, 1.92]

2.3 Infected

1

72

Risk Ratio (M‐H, Fixed, 95% CI)

1.03 [0.60, 1.75]

3 Length of hospital stay Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 1.3

Comparison 1 Adhesive drapes versus no adhesive drapes, Outcome 3 Length of hospital stay.

Comparison 1 Adhesive drapes versus no adhesive drapes, Outcome 3 Length of hospital stay.

3.1 Infected wound

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 No infected wound

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

Open in table viewer
Comparison 2. Iodine‐impregnated adhesive drapes versus no adhesive drapes

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Surgical site infection Show forest plot

2

1113

Risk Ratio (M‐H, Fixed, 95% CI)

1.03 [0.66, 1.60]

Analysis 2.1

Comparison 2 Iodine‐impregnated adhesive drapes versus no adhesive drapes, Outcome 1 Surgical site infection.

Comparison 2 Iodine‐impregnated adhesive drapes versus no adhesive drapes, Outcome 1 Surgical site infection.

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
Figuras y tablas -
Figure 1

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Figuras y tablas -
Figure 2

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

Comparison 1 Adhesive drapes versus no adhesive drapes, Outcome 1 Surgical site infection (all wound classifications).
Figuras y tablas -
Analysis 1.1

Comparison 1 Adhesive drapes versus no adhesive drapes, Outcome 1 Surgical site infection (all wound classifications).

Comparison 1 Adhesive drapes versus no adhesive drapes, Outcome 2 Surgical site infection (by wound classification).
Figuras y tablas -
Analysis 1.2

Comparison 1 Adhesive drapes versus no adhesive drapes, Outcome 2 Surgical site infection (by wound classification).

Comparison 1 Adhesive drapes versus no adhesive drapes, Outcome 3 Length of hospital stay.
Figuras y tablas -
Analysis 1.3

Comparison 1 Adhesive drapes versus no adhesive drapes, Outcome 3 Length of hospital stay.

Comparison 2 Iodine‐impregnated adhesive drapes versus no adhesive drapes, Outcome 1 Surgical site infection.
Figuras y tablas -
Analysis 2.1

Comparison 2 Iodine‐impregnated adhesive drapes versus no adhesive drapes, Outcome 1 Surgical site infection.

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

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No. of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Adhesive drapes versus no adhesive drapes

Surgical site infection (all wound classifications)
Inspection of the wound1
(follow‐up: 5 to 24 weeks2)

Medium risk population

RR 1.23
(1.02 to 1.48)

3082
(5)

⊕⊕⊕⊕
High3,4

109 per 1000

134 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.

Figuras y tablas -

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

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No. of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

No adhesive drapes

Iodophore‐impregnated adhesive drapes

Surgical site infection
Inspection of the wound1
(follow‐up: 3 to 6 weeks)

Medium risk population

RR 1.03
(0.66 to 1.6)

1113
(2)

⊕⊕⊕⊝
Moderate2,3

45 per 1000

46 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.

Figuras y tablas -
Comparison 1. Adhesive drapes versus no adhesive drapes

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Surgical site infection (all wound classifications) Show forest plot

5

3082

Risk Ratio (M‐H, Fixed, 95% CI)

1.23 [1.02, 1.48]

2 Surgical site infection (by wound classification) Show forest plot

1

921

Risk Ratio (M‐H, Fixed, 95% CI)

1.20 [0.86, 1.66]

2.1 Clean

1

363

Risk Ratio (M‐H, Fixed, 95% CI)

1.37 [0.53, 3.53]

2.2 Potentially infected

1

486

Risk Ratio (M‐H, Fixed, 95% CI)

1.24 [0.80, 1.92]

2.3 Infected

1

72

Risk Ratio (M‐H, Fixed, 95% CI)

1.03 [0.60, 1.75]

3 Length of hospital stay Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

3.1 Infected wound

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 No infected wound

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 1. Adhesive drapes versus no adhesive drapes
Comparison 2. Iodine‐impregnated adhesive drapes versus no adhesive drapes

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Surgical site infection Show forest plot

2

1113

Risk Ratio (M‐H, Fixed, 95% CI)

1.03 [0.66, 1.60]

Figuras y tablas -
Comparison 2. Iodine‐impregnated adhesive drapes versus no adhesive drapes