1. Introduction
Sterile surgical drapes are used during surgery to prevent contact with unprepared surfaces and to maintain the sterility of environmental surfaces, equipment and the patient’s surroundings. Similarly, sterile surgical gowns are worn over the scrub suit of the operating team during surgical procedures to maintain a sterile surgical field and reduce the risk of transmission of pathogens to both patients and staff.
Surgical gowns and drapes are fabricated from either multiple- or single-use materials. There is considerable variation in design and performance characteristics within each of these two broad categories, which reflects the necessary trade-offs in economy, comfort and degree of protection required for particular surgical procedures1.
During surgical procedures, the risk of pathogen transmission increases if the barrier materials become wet. Consequently, the multiple- or single-use materials of the drapes and gowns used in a surgical procedure should prevent the penetration of liquids. Reusable materials are typically composed of different tightly-woven textiles and/or knitted cotton, or other fabrics possibly blended with polyester and/or chemically treated. These products have to be durable and provide protection after many cycles of processing and treatment. Disposable surgical drapes and gowns are typically composed of non-woven materials of synthetic and/or natural origin, possibly combined with chemical treatment2.
Adhesive plastic incise drapes, plain or impregnated with an antimicrobial agent (mostly an iodophor), are used on the patient’s skin after the completion of surgical site preparation. The film adheres to the skin and the surgeon cuts through the skin and the drape itself3. Such a drape is theoretically believed to represent a mechanical and/or microbial barrier to prevent the migration of microorganisms from the skin to the operative site4. However, some reports showed an increased recolonization of the skin following antiseptic preparation underneath adhesive drapes compared to the use of no drapes5.
A Cochrane review6 and its updates3,7 on the effect of adhesive incise drapes for the prevention of surgical site infection (SSI) found that there is no evidence that plastic adhesive drapes reduce SSI. No recommendation is available on the use of disposable or reusable drapes and gowns. The guidelines of the Society for Healthcare Epidemiology of America (SHEA)/Infectious Diseases Society of America (IDSA) issued in 2014 recommend that plastic adhesive drapes with or without antimicrobial properties should not be used routinely as a strategy to prevent SSI8. Nevertheless, the United Kingdom (UK) National Institute for Health and Care Excellence (NICE) issued a guideline in 2008, which recommends that an iodophor-impregnated drape should be used if a plastic adhesive drape is required9.
3. Methods
The following databases were searched: Medline (PubMed); Excerpta Medica database (EMBASE); Cumulative Index to Nursing and Allied Health Literature (CINAHL); Cochrane Central Register of Controlled Trials (CENTRAL); and the WHO Global Health Library. The time limit for the review was between 1 January 1990 and 31 December 2014; no language restriction was applied. A comprehensive list of search terms was used, including Medical Subject Headings (MeSH) (Appendix 1).
Two independent reviewers screened titles and abstracts of retrieved references for potentially relevant studies. The full text of all potentially eligible articles was obtained. Two authors independently reviewed the full text articles for eligibility based on inclusion criteria. Duplicate studies were excluded. Two authors extracted data in a predefined evidence table (Appendix 2) and critically appraised the retrieved studies. Quality was assessed using the Cochrane Collaboration tool to assess the risk of bias of randomized controlled studies (RCTs)10 (Appendix 3a) and the Newcastle-Ottawa Quality Assessment Scale for cohort studies (Appendix 3b)11. Any disagreements were resolved through discussion or after consultation with the senior author, when necessary.
Meta-analyses of available comparisons were performed using Review Manager v5.3 as appropriate12 (Appendix 4). Adjusted odds ratios (OR) with 95% confidence intervals (CI) were extracted and pooled for each comparison with a random effects model. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology13 (GRADE Pro software) was used to assess the quality of the body of retrieved evidence (Appendix 5).
5. Summary of the findings and quality of the evidence
Eleven studies14–24 (4 randomized controlled trials [RCTs]14,20,23,24, 2 quasi-RCTs15,19 and 5 observational studies16–18,21,22) comparing overall the use of disposable non-woven drapes and gowns vs. reusable woven drapes and gowns were identified with SSI as the primary outcome.
Findings related to PICO question 1
Five studies (one RCT14, one quasi-RCT15 and 3 observational studies16–18) compared disposable non-woven drapes and gowns vs. reusable woven drapes and gowns and disposable non-woven drapes vs. reusable, woven drapes (Appendix 2). The literature search did not identify any studies focusing on gowns only (comparing disposable non-woven gowns with reusable woven gowns).
After careful appraisal of the studies, the following two comparisons were performed:
- 1.1.
Disposable non-woven drapes and gowns vs. reusable woven drapes and gowns.
- 1.2.
Disposable non-woven drapes vs. reusable woven drapes.
Results according to the comparisons
1.1 Four studies (one RCT14, one quasi-RCT15, and 2 observational studies16,18) compared the use of disposable non-woven drapes and gowns vs. reusable woven drapes and gowns to decrease the risk of SSI. These studies included clean and clean-contaminated general surgery, orthopaedic, neurosurgery, plastic cardiothoracic and coronary artery surgical procedures. Types and materials of disposable and reusable drapes and gowns differed between studies (Appendix 2).
The effect of the intervention varied among the studies. One study15 reported that the use of disposable non-woven drapes may be beneficial for the reduction of SSI, but the effect estimate was not statistically significant. Two studies14,18 estimated that there was no difference between the intervention and the control group, and one study16 showed that using the intervention may have some harm, but this was not statistically different from the control group.
Meta-analysis of the RCT and the quasi-RCT showed that the use of disposable non-woven drapes and gowns has neither benefit nor harm compared to the use of reusable drapes and gowns (OR: 0.85; 95% CI: 0.66–1.09). In addition, the meta-analysis of the 2 observational studies showed a similar result (OR: 1.56; 95% CI: 0.89–2.72]). (Appendix 4, comparison 1.1).
The quality of the evidence for this comparison was moderate for the RCTs and very low for the observational studies, both due to imprecision (Appendix 5).
1.2 One study17 was identified comparing the use of disposable fenestrated drapes designed originally for cardiac catheterization with traditional draping that involved the use of multiple reusable cloth drapes. The study showed that the intervention may have some effect to reduce SSI (OR: 0.07; 95% CI: 0.01–0.61) (Appendix 4, comparison 1.2).
There are limitations to this analysis. There are only a few studies available on this topic. In addition, studies used different SSI definitions and different types and material of drapes and gowns. In one study17, surgical procedures in the intervention group were performed by the senior experienced surgeons, while they were done by less experienced surgeons in the control group. In an observational study with a before/after design16, potential bias may have been introduced due to two study periods. In one study18, postoperative follow-up was for 10 days only.
2. No studies related to PICO question 2 were identified (assessment of whether changing drapes during operations affects the risk of SSI).
3. Findings related to PICO question 3
Six studies (3 RCTs20,23,24, one quasi-RCT19 and 2 observational studies21,22) comparing single-use disposable adhesive incise drapes (antimicrobial-impregnated or nonimpregnated) to non-adhesive incise drapes for the reduction of the risk of SSI were identified.
After careful appraisal of the studies, the following 2 comparisons were performed:
- 3.1.
Adhesive antimicrobial-impregnated incise drapes vs. no drapes.
- 3.2.
Adhesive non-impregnated incise drapes vs. no drapes.
Results according to the comparisons
3.1 Four studies (one RCT20, one quasi-RCT19 and 2 observational studies21,22) were identified that assessed the effect of using single-use adhesive incise drapes to reduce SSI. Patients were adults undergoing elective clean and clean-contaminated surgical procedures (open appendectomy, cardiac, laparoscopic ventral and incisional hernia repair and liver resection for hepatocellular carcinoma). Three studies used the same iodine-impregnated antimicrobial film incise drape and one did not specify the type used.
The effect varied among the included studies. The 2 RCTs showed that the use of antimicrobial-impregnated incise drapes may have some harm, but the effect estimate was not statistically different from the control group. By contrast, the observational studies reported that there may be a benefit in using antimicrobial-impregnated incise drapes, but the effect was also not statistically different from the control group.
Meta-analysis of the 2 RCTs showed that the use of antimicrobial-impregnated incise drapes has neither benefit nor harm compared to no drapes in reducing SSI (OR: 2.62; 95% CI: 0.68–10.04). The meta-analysis of the 2 observational studies showed a similar result (OR: 0.49; 95% CI: 0.16 – 1.49) (Appendix 4, comparison 3.1).
The quality of evidence for these comparisons was very low for both the RCTs and the observational studies due to the risk of bias and imprecision or inconsistency (Appendix 5).
3.2 Two RCTs23,24 evaluated the effect of using non-antimicrobial-impregnated adhesive incise drapes vs. no drapes to reduce SSI. Both studies used the same type and brand of non-impregnated adhesive incise drapes. Patients were adults undergoing fixation of hip fractures in one study and caesarean section in the other. No observational studies were identified for this comparison. Despite the difference in patient population and surgical procedures, the effect estimate reported was similar in both studies.
Meta-analysis of the 2 RCTs showed that the use of non-antimicrobial-impregnated incise drapes has neither benefit nor harm compared to no drapes in reducing SSI (OR: 1.10; 95% CI: 0.68 – 1.78) (Appendix 4, comparison 3.2).
The quality of evidence for this comparison was low due to imprecision (Appendix 5).
There is a limitation to this analysis as the number of studies is small with small sample sizes and different surgical procedures. A methodological risk of bias was identified in the design of the included studies, including variations in the definition of SSI and the duration of patient follow-up postoperatively.
In conclusion, an overall very low (RCTs and observational studies) quality of evidence shows that the use of disposable single-use drapes and gowns is neither beneficial nor harmful in reducing the SSI rate when compared to reusable drapes and gowns. No evidence was retrieved to evaluate the effect of an intraoperative change of drapes on the SSI rate. Again, an overall very low (RCTs and observational studies) quality of evidence shows that the use of antimicrobial-impregnated incise drapes has neither benefit nor harm compared to no drapes in reducing SSI. An overall low (2 RCTs) quality of evidence shows that the use of non-antimicrobial-impregnated incise drapes has neither benefit nor harm compared to no drapes in reducing SSI.
6. Other factors considered in the review of studies
The systematic review team identified the following other factors to be considered.
Potential harms
Adhesive bands of single-use drapes are reported to have a potential to provoke skin rash or eczema16. Allergic reactions are possible adverse events, for example, allergic contact dermatitis associated with the use of iodophor-impregnated drapes25.
Resource use
There are many different aspects that need to be taken into account when evaluating the resource implications for the use of disposable vs. reusable drapes and surgical gowns. These include, but are not limited to, direct purchase costs and costs related to laundry and sterilization, labour and waste disposal26. Two studies27,28 showed lower costs associated with the use of disposable drapes and gowns, whereas a cost-benefit analysis26 found costs to be relatively higher for disposable drapes and gowns compared with reusable ones. Other authors reported that costs were similar for disposable and reusable items29,30. The heterogeneous findings of the available data on resource implications suggest that disposable and reusable surgical drapes and gowns are probably similar in costs.
Limited availability and costs may represent a burden in low- and middle-income countries (LMICs), whereas labour costs may be less of an issue compared to high-income countries. The disposal of single-use drapes and gowns and the ecological impact should be considered as their use generates additional clinical waste. Finally, the availability of adhesive incise drapes in LMICs may be limited and the purchase represents a high financial burden. Considering the lack of evidence for any benefit for the prevention of SSI, the additional cost for plastic adhesive incise drapes is not justified, irrespective of the setting.
7. Key uncertainties and future research priorities
The available evidence is limited and comes mainly from high-income countries. More well-designed RCTs investigating the use of disposable drapes and surgical gowns compared to reusable drapes and surgical gowns in terms of SSI prevention are needed, especially in LMICs. One of the main research priority areas is to investigate whether drapes should be changed during the operation and if this measure has an effect on SSI rates. Further research should focus also on different types of materials (including permeable and impermeable materials) and address environmental concerns (water, energy, laundry, waste, etc.). Cost-effectiveness analyses of disposable compared to reusable drapes and gowns are very welcome, particularly in LMICs. The use of adhesive incise drapes is not considered a high priority topic in the field of SSI prevention research. Nevertheless, well-designed RCTs are encouraged to further investigate the potential benefits of these products, which are aggressively promoted by the manufacturing companies.
%20vs.%20no%20adhesive%20incise%20drapes.&p=BOOKS&id=536409_webapp17f9.jpg "Click on image to zoom")