t h e s u r g e o n 1 2 ( 2 0 1 4 ) 4 7 e5 2
Available online at www.sciencedirect.com
ScienceDirect The Surgeon, Journal of the Royal Colleges of Surgeons of Edinburgh and Ireland www.thesurgeon.net
Review
Surgical attire, practices and their perception in the prevention of surgical site infection S.M. McHugh a,*, M.A. Corrigan a, A.D.K. Hill a,b, H. Humphreys c,d a
Department of Surgery, Royal College of Surgeons in Ireland, Dublin 2, Ireland Department of Surgery, Beaumont Hospital, Dublin 9, Ireland c Department of Clinical Microbiology, Royal College of Surgeons in Ireland, Dublin 2, Ireland d Department of Microbiology, Beaumont Hospital, Dublin 9, Ireland b
article info
abstract
Article history:
Introduction: Clean surgical scrubs, surgical gowns and headgear are worn by operative
Received 16 September 2013
teams to decrease bacterial contamination and lower surgical site infection (SSI) rates.
Received in revised form
Methods: A detailed review was undertaken of peer-reviewed publications and other
10 October 2013
sources of material in the English language over the last 50 years included.
Accepted 10 October 2013
Results: Surgical scrubs should be clean and made of tightly woven material. Studies
Available online 20 November 2013
investigating single-use gowns and drapes versus reusable gowns report conflicting evidence. Double gloving may reduce SSI rates in procedures where no antibiotic prophylaxis
Keywords:
was administered. Bacterial contamination of the operative field has been shown to be
Surgical attire
decreased by the wearing of surgical headgear by the operating team.
Surgical site infection
Conclusions: Further consideration and better trials are required to determine the impact of
SSI
different theatre clothing on SSI rates.
Infection prevention
ª 2013 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.
Introduction Approximately 5% of patients undergoing surgery develop a surgical site infection (SSI).1 Patients who develop SSI are up to 60% more likely to spend time in an intensive care unit, five times more likely to be readmitted to the hospital, and twice as likely to die than are patients without an SSI.2 Furthermore, post-operative length of hospital stay is extended by 7e10 days leading to substantially increased overall care costs.2e7 Factors associated with SSI can be either intrinsic or extrinsic. Intrinsic patient factors are not reversible, such as diabetes mellitus. Extrinsic factors are those in which
adherence to best practice can decrease SSI.8 Standard procedures for the prevention of SSI include pre-operative patient preparation, appropriate prophylactic antibiotics, careful and skilled surgical technique, intra-operative medical management and post-operative surgical site or wound care.9e11 Practices in the operating theatre complex therefore should be considered as extrinsic factors. This is a restricted area with emphasis on the need for sterility and aseptic techniques compared with pathogen-residing areas such as hospital wards,12 with the use of clean surgical attire (i.e. scrubs, caps, masks, gloves and gowns) strictly regulated.9 Most surgeons have strong opinions on surgical attire,
* Corresponding author. Beaumont Hospital, Dublin 9, Ireland. Tel.: þ353 01 8093000. E-mail address: [email protected] (S.M. McHugh). 1479-666X/$ e see front matter ª 2013 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.surge.2013.10.006
48
t h e s u r g e o n 1 2 ( 2 0 1 4 ) 4 7 e5 2
although many are based on behaviour and ritual rather than evidence based medicine.13 In this article we review evidence based best practice with regard to surgical attire in the field of general surgery.
Methods A detailed literature review was undertaken through www. Pubmed.com and Google scholar (http://scholar.google.com). Surgical attire was defined as the wearing of clean surgical scrubs and footwear in the operating theatre complex and the wearing of surgical caps, masks, gowns and gloves for the operating team. Search terms used included “surgical attire”. “surgical scrubs”, “surgical site infection prevention”, “surgical masks”, “surgical caps”, “surgical gowns”, “surgical gloves”, “surgical shoes” and “surgical footwear”. Peerreviewed publications in the English language over the last 50 years were included, up to and including June 2013.
Results Surgical scrubs In current practice it is a widely held opinion of healthcare professionals that the wearing of clean surgical scrubs in restricted areas of healthcare facilities such as the operating theatre helps ensure cleanliness and reduces infections by limiting the introduction of microorganisms from healthcare personnel to the theatre environment.12,14 From the patient’s perspective, a study ascertaining their attitudes of the risks of cross-infection through healthcare workers attire has found that surgical scrubs are believed to be the most appropriate attire to prevent infection.15 While there has been no study demonstrating a direct link between non-sterile surgical attire and increased surgical site infections,13,14 the skin of staff working in the operating theatre is known to be a major source of bacteria dispersed into the air.16 Bacteria are dispersed on epithelial cells that break fragments of approximately 20 mm in size. Given that the interstices of standard cotton fabric have a pore size of 80 100 mm these fragments are small enough to pass through such fabrics. As such recent Association of Perioperative Registered Nurses (AORN) guidelines recommend that the scrub material should be tightly woven, as well as low-linting, stain resistant and durable.12 With regard to the wearing of surgical scrubs when leaving the theatre complex for a short period, e.g. to attend a multidisciplinary team meeting, a study by Copp et al. reported reduced levels of contamination on surgical scrubs when cover gowns were worn outside the operating room.17 Surgeons’ attitudes differ depending on speciality, with orthopaedic surgeons more likely to change to regular clothing when leaving the theatre complex compared with general surgeons.18 However, theatre nurses have been shown to be especially compliant with regulations restricting surgical attire outside the theatre complex.13,14,19,20 Guidelines issued by the then National Association of Theatre Nurses (now the Association for Perioperative Practice, AfPP) in the UK state
that the covering apparel worn when leaving the theatre complex must be a “clean single use gown or coat, completely secured by ties or button fasteners, which is worn once and then appropriately discarded”.20 The wearing of a white coat over surgical scrubs when leaving the operating theatre complex is controversial with some institutions advocating this practice but others arguing that pathogens living on scrub suits worn by healthcare personnel may still spread infection.14,21,22
Recommendations Surgical scrubs should be clean and made of tightly woven material. However, there is little research evidence to demonstrate that wearing surgical attire outside the theatre and returning to the theatre without changing into clean theatre suits increases SSI rates. In addition, there are no convincing studies demonstrating a relationship between the use of covering apparel and the prevention of infection. Nonetheless, given that surgical scrubs are used to minimise bacteria being shed by the operator, common sense dictates that surgeons should only leave the operating theatre complex when necessary, but when and if they do, they should cover the scrubs when outside the theatre complex or change in to new scrubs on returning to re-commence operating.
Surgical gowns As well as preventing bacteria from the skin of the operating team contaminating the sterile field, surgical gowns also fulfil the dual role of protecting the team from being contaminated by blood from the patient.13 In current clinical practice surgical gowns and drapes are fabricated from either multiple- or single-use materials. These two basic types of products each have advantages and disadvantages.23 With regard to reusable surgical gowns, there are two available types. The first is tightly woven polyester sheeting and the second a combination of fabrics laminated or coated with various types of films that provide increased protection.24 Single use surgical gowns consist of nonwoven materials such as spunlace hydroentangled material often consisting of wood pulp and polyester fibres. These are often in combination with materials that offer increased protection from liquid penetration such as plastic films.23e25 A number of previous studies have previously compared the use of reusable versus single-use gowns and drapes in the prevention of surgical site infection. A study by Moylan et al. involving 2181 general surgical procedures was performed to evaluated the effectiveness of a disposable gown and drape system versus a cotton system.26 The study end point was the development of SSI. They noted that the disposable spunlaced fibre system had a significantly lower overall infection rate (2.83% vs. 6.5%). However this study was not a randomised prospective trial. Garibaldi et al. in a comparative study took surgical site intra-operative swabs taken from the surgical site at time of skin closure. This study was a prospective randomised controlled trial (RCT). They noted no significant difference between procedures where reusable cotton gowns and drapes were used compared with nonwoven disposable material
t h e s u r g e o n 1 2 ( 2 0 1 4 ) 4 7 e5 2
(15.5% vs. 13.1% p > 0.05). In addition post-operative SSI rates were not significantly different between the two groups.27 More recently a UK study randomised 505 patients undergoing coronary artery surgery in a single hospital over an 18month period to either a disposable, paper gown and drape system, or a reusable fabric system. There was no significant difference in the rates of sternal or leg SSIs between the two groups (p ¼ 0.87 and 0.62, respectively).28
Recommendations Current European standards recommend against the further use of cotton and polyester/cotton-blended drapes and surgical gowns.29 However given the conflicting evidence, additional larger and multi-centre studies using currently available single-use gowns and drapes versus reusable gowns will be required if difficult to fund and therefore conduct. Such studies would be prospective randomised controlled trials taking into account other variables such as antimicrobial prophylaxis.23
Surgical headgear In practice the wearing of disposable caps and masks in operating theatres have been recommended for scrubbed and non-scrubbed staff. Humphreys et al. studied the effect of surgical headgear on bacterial air counts in a sealed room, with and without ventilation. They found that the wearing of headgear was not associated with a reduction in air counts, and recommended that non-scrubbed staff in theatre no longer routinely wear headgear unless involved in a high risk surgical procedure such as the insertion of a prosthesis, as effective ventilation counteracts any increased bacterial shedding.30 A further UK study also used colony forming unit (cfu) measurement on settle plates placed at head and waist height in the operating surgeon and air samplers in the operating theatre to determine bacterial air count in ultraclean (enclosed vertical laminar-flow) and conventional (plenum ventilated) airflow theatres.31 In conventional theatres, the study reported a wide variation in colony counts, and no consistent benefit from surgical headgear was demonstrated. However in a laminar air-flow “ultra-clean” theatre there was 22 times the number of organisms on the settle plates when operating staff did not wear surgical headgear with no significant concurrent increase in air sample counts. Previous studies have suggested an increased degree of bacterial shedding on to the operative field when no facemask is worn. A study by Berger et al. assessed 30 cardiac catheterisation procedures. The number of bacterial colonies recoverable when no mask was worn was significantly higher than that detected when a full mask was worn (p < 0.002).32 This finding was echoed by a further study from the UK.33 Here a blood agar plate was placed 30 cm directly below the lips of 20 volunteers without a face mask for the first 5 min and then with a standard, soft pleated face mask for the subsequent 15 min. Analysis showed a significant reduction in the number of colonies cultured per plate when the mask was worn. A correlation with increased SSI rates has not, however, been previously demonstrated. A controlled, prospective
49
study of over 3000 patients recorded the incidence of SSI over a two-year period in general surgery. Results were statistically insignificant with the ‘masked’ operations having an infection rate of 4.7% compared 3.5% in those ‘unmasked’.34 Filtered exhaust helmets and gowns (space suits) have also been investigated predominantly in an orthopaedic setting with regard to efficacy in infection prevention. Previous reports noted a decreased SSI rate from 7.6% to 1.6% in orthopaedic surgery with the use of helmet aspirator systems and laminar airflow theatres.35 However control of concurrent SSIrelated variables has been lacking in previous studies, making support of such conclusions debatable.36 A more recent study comparing conventional cap and mask headgear with filtered exhaust helmets assessed air and surface contamination in 30 sham operations. They noted a 60-fold increase of bacterial sedimentation rate in the wound area when the filtered exhaust helmets were not used.37 However a 2003 study of 62 hip arthroplasties in 2003 noted that body exhaust gowns and headgear provided comparable protection to conventional attire in terms of numbers of colony forming units on settle plates in laminar airflow operating theatres.38
Recommendations Overall, conventional airflow theatres there is little evidence to suggest that the wearing of surgical facemasks or caps by non-scrubbed theatre staff reduces SSI rates. However, bacterial contamination of the operative field has been shown to be decreased by the wearing of surgical headgear by the operating team. Consideration must be given therefore in general surgical cases where grafts or prosthesis (i.e. synthetic vascular grafts) are being used to ensuring correct surgical headgear is appropriately worn.
Surgical gloves The use of gloves in surgery has evolved over time with early studies confirming a significant decrease in SSI with the use of gloves.39 Current debate centres on whether double gloving can reduce the risk of SSI. Double gloving has two purposes; to contribute to reduction in SSI through minimising contamination of the operative field arising from perforation and protecting the operative team from blood borne virus acquisition such as hepatitis B. A 2006 Cochrane review of 14 randomised controlled trials comparing double gloving versus single gloving found significantly more perforations in the single glove group than the inner gloves of the double glove group.40 The review found that the addition of a second pair of surgical gloves significantly reduced perforations of the innermost gloves. In addition, knitted outer gloves and glove liners also significantly reduce perforations to the innermost glove. Perforation indicator systems such as the wearing of coloured inner gloves were also seen to result in significantly more innermost glove perforations being detected during surgery. It has been traditional teaching that gloves should be changed promptly if punctured.41 However, there has not been a study conclusively demonstrating an increased risk of SSI associated with glove punctures intra-operatively. In fact several studies have demonstrated no increase in bacterial contamination of the surgeons’ hands on the outside of the
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Table 1 e Summary of contentious issues, evidence and recommendations. Contentious issues
Evidence
Wearing scrubs outside of the operatingtheatre complex
No randomised controlled trials. Best practice recommendations from AfPP
The use of reusable versus single-use gowns and drapes in the prevention of surgical site infection
Two RCTs. Prospective, non-randomised study. Best practice recommendations from CEN
The wearing of facemasks and caps decreases SSI rates
Studies of settle plates in the surgical field. Nonrandomised clinical prospective study of >3000 patients Cochrane review of 14 RCTs. Two prospective cohort studies of >10,000 patients
Double gloving reduces SSI rates
surgical gloves during operations when gloves were shown to be punctured.42e44 One such study involving patients undergoing biliary surgery noted no transfer of skin bacteria from the operating team through the perforated gloves to the operative field.42 Similarly, both Ritter et al.43 and McCue et al.44 demonstrated that areas of contamination on surgical gloves examined after the procedure did not correspond with glove puncture locations in gloves that had been perforated. Despite these findings a more recent study from a team of Swiss researchers has linked glove perforation with increased SSI rates.45 This was a prospective cohort study involving 4147 surgical procedures. Multivariate analysis showed an increased risk of SSI in procedures where there was glove perforation and when antibiotic prophylaxis had not been administered (odds ratio 4.2 p ¼ 0.003). When antibiotic prophylaxis was used the incidence of SSI was not significantly increased in cases where gloves were punctured. This finding was lent further weight by a 2012 study of 6283 consecutive general surgical procedures followed for a one year period. Here glove perforation in the absence of systemic antibiotic prophylaxis was also found to significantly increase the risk of SSI (OR 2.0; CI 1.4e2.8; p < 0.001).46 This raises the potential importance of double gloving in reducing SSI only in cases where antibiotic prophylaxis has not been routinely administered (i.e. clean procedures), when it is inadvertently omitted or given at an inappropriate time, e.g. after the initial incision. Gloves impregnated with antimicrobials represent a novel approach to decreasing contamination after glove perforation. A recent study assessed microbial passage between glove layers in those wearing single gloves, double gloves and antimicrobial trilayer gloves. A significant reduction in microbial passage was noted in those wearing trilayer antimicrobial gloves.47 Wearing a third layer of sterile gloves itself has previously been reported to decrease glove perforation rates.40 However while double gloving has been reported to have no substantial impact on function or tactile sensitivity in
Conclusions
References
Theatre staff should wear a single use cover gown or coat which should be discarded when returning to the theatre complex Decreased SSI rate in single use gowns in non-randomised study. Randomised trials demonstrated no significant difference. European standards recommend single use gowns and drapes Little evidence to suggest that the wearing of surgical facemasks and caps reduces SSI rates. Bacterial contamination of the operative field has been shown to be decreased Double gloving reduces glove perforation rate. Double gloving may reduce SSI rates in procedures where antibiotic prophylaxis is not given.
14,20e22
26e29
31e34
40,45,46
surgeons,48 wearing a third layer of gloves may compromise surgical dexterity.
Recommendations Double gloving has been shown to decrease glove perforation rates. However, debate remains as to whether increased glove perforation rates lead to increased SSI incidence. Recent studies suggest that double gloving reduces SSI risk in clean procedures where antibiotic prophylaxis is not used without compromising manual dexterity of the surgical team.40 Double gloving is also recommended to decrease the risk of occupational acquisition of a blood borne virus such as hepatitis B when the operation involves a bloody field and there is glove perforation with or without an injury to the operator.
Conclusions There exists on-going debate about the efficacy of different aspects of surgical attire such as double gloving to decrease SSI rates (Table 1). The wearing of clean surgical scrubs, surgical gowns and headgear for operating teams helps decrease bacterial contamination. Double gloving decreases the glove perforation rate, which may impact on SSI rates in cases where antibiotic prophylaxis is not given. In a general sense the donning of surgical attire helps to demarcate the operating theatre complex from the rest of the hospital indicating a separate but high risk zone requiring extra efforts in asepsis to prevent infection. By making theatre personnel change to specific surgical scrubs, shoes and hats before entering the theatre complex, this ritualistic behaviour serves as a daily reminder of the importance of sterility and infection prevention practices in the operating theatre. Further work is required to determine the impact of theatre clothing on SSI rates as its unnecessary use represents a significant cost and an environmental issue in terms of disposal. However, RCTs in multiple centres as would probably be
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required to address these questions are probably not feasible. Data could be collected from many national surveillance programmes of SSI as exist elsewhere such as in the Netherlands and Germany on practices.49,50 This information could be collated with SSI rates to determine the impact of surgical attire on infection rates, while allowing for risk factors and case mix.
references
1. Gottrup F. Prevention of surgical-wound infections. N Engl J Med 2000;342(3):202e4. 2. Kirkland KB, Briggs JP, Trivette SL, Wilkinson WE, Sexton DJ. The impact of surgical-site infections in the 1990s: attributable mortality, excess length of hospitalization, and extra costs. Infect Control Hosp Epidemiol 1999;20(11):725e30. 3. Hollenbeak CS, Murphy D, Dunagan WC, Fraser VJ. Nonrandom selection and the attributable cost of surgicalsite infections. Infect Control Hosp Epidemiol 2002;23(4):177e82. 4. Burke JP. Infection control e a problem for patient safety. N Engl J Med 2003;348(7):651e6. 5. Perencevich EN, Sands KE, Cosgrove SE, Guadagnoli E, Meara E, Platt R. Health and economic impact of surgical site infections diagnosed after hospital discharge. Emerg Infect Dis 2003;9(2):196e203. 6. Poulsen KB, Bremmelgaard A, Sorensen AI, Raahave D, Petersen JV. Estimated costs of postoperative wound infections. A case-control study of marginal hospital and social security costs. Epidemiol Infect 1994;113(2):283e95. 7. Vegas AA, Jodra VM, Garcia ML. Nosocomial infection in surgery wards: a controlled study of increased duration of hospital stays and direct cost of hospitalization. Eur J Epidemiol 1993;9(5):504e10. 8. NICE. Prevention and treatment of surgical site infection; 2008. 9. Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol 1999;20(4):250e78 [quiz 279e80]. 10. McHugh SM, Hill AD, Humphreys H. Intraoperative technique as a factor in the prevention of surgical site infection. J Hosp Infect 2011;78(1):1e4. 11. McHugh SM, Collins CJ, Corrigan MA, Hill AD, Humphreys H. The role of topical antibiotics used as prophylaxis in surgical site infection prevention. J Antimicrob Chemother 2011;66(4):693e701. 12. Recommended practices for surgical attire. AORN J 2005;81(2):413e20. 13. Woodhead K, Taylor EW, Bannister G, Chesworth T, Hoffman P, Humphreys H. Behaviours and rituals in the operating theatre. A report from the Hospital Infection Society Working Party on Infection Control in Operating Theatres. J Hosp Infect 2002;51(4):241e55. 14. Braswell ML, Spruce L. Implementing AORN recommended practices for surgical attire. AORN J 2012;95(1):122e37 [quiz 138e40]. 15. Shelton CL, Raistrick C, Warburton K, Siddiqui KH. Can changes in clinical attire reduce likelihood of cross-infection without jeopardising the doctor-patient relationship? J Hosp Infect 2010;74(1):22e9. 16. Mitchell NJ. Skin bacteria and theatre clothing. Hosp Equip Supplies 1976;22(1):10e1. 17. Copp G, Mailhot CB, Zalar M, Slezak L, Copp AJ. Covergowns and the control of operating room contamination. Nurs Res 1986;35(5):263e8. 18. Weinbroum AA, Ezri T, Harow E, Tsivian A, Serour F. Wearing surgical attire outside the operating room: a survey of habits
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of anesthesiologists and surgeons in Israel. J Am Coll Surg 2007;205(2):314e8. Perry C, Marshall R, Jones E. Bacterial contamination of uniforms. J Hosp Infect 2001;48(3):238e41. Rohrlach G. Does NATN have any advice or research available about home laundering of scrub attire? Br J Perioper Nurs 2001;11(3):101. Lafreniere R, Bohnen JM, Pasieka J, Spry CC. Infection control in the operating room: current practices or sacred cows? J Am Coll Surg 2001;193(4):407e16. Kaplan C, Mendiola R, Ndjatou V, Chapnick E, Minkoff H. The role of covering gowns in reducing rates of bacterial contamination of scrub suits. Am J Obstet Gynecol 2003;188(5):1154e5. Rutala WA, Weber DJ. A review of single-use and reusable gowns and drapes in health care. Infect Control Hosp Epidemiol 2001;22(4):248e57. Technical Information Report Association for the Advancement of Medical Instrumentation. Selection of surgical gowns and drapes in health care facilities. Arlington, VA: Association for the Advancement of Medical Instrumentation; 1994. Rainford S, Yannetta I, Hunt G. Surgical gowns. Infect Control Today 1998;1:21e2. Moylan JA, Kennedy BV. The importance of gown and drape barriers in the prevention of wound infection. Surg Gynecol Obstet 1980;151(4):465e70. Garibaldi RA, Maglio S, Lerer T, Becker D, Lyons R. Comparison of nonwoven and woven gown and drape fabric to prevent intraoperative wound contamination and postoperative infection. Am J Surg 1986;152(5):505e9. Bellchambers J, Harris JM, Cullinan P, Gaya H, Pepper JR. A prospective study of wound infection in coronary artery surgery. Eur J Cardiothorac Surg 1999;15(1):45e50. CEN. Surgical clothing and drapes used as medical devices in healthcare facilities. Second Draft. CEN/TC 205/WG 14 N 61. Humphreys H, Russell AJ, Marshall RJ, Ricketts VE, Reeves DS. The effect of surgical theatre head-gear on air bacterial counts. J Hosp Infect 1991;19(3):175e80. Hubble MJ, Weale AE, Perez JV, Bowker KE, MacGowan AP, Bannister GC. Clothing in laminar-flow operating theatres. J Hosp Infect 1996;32(1):1e7. Berger SA, Kramer M, Nagar H, Finkelstein A, Frimmerman A, Miller HI. Effect of surgical mask position on bacterial contamination of the operative field. J Hosp Infect 1993;23(1):51e4. McLure HA, Talboys CA, Yentis SM, Azadian BS. Surgical face masks and downward dispersal of bacteria. Anaesthesia 1998;53(7):624e6. Tunevall TG. Postoperative wound infections and surgical face masks: a controlled study. World J Surg 1991;15(3):383e7 [discussion 387e8]. Nelson JP. Five years experience with operating room clean rooms and personnel-isolator systems. Med Instrum 1976;10(6):277e81. Shaw JA, Bordner MA, Hamory BH. Efficacy of the steri-shield filtered exhaust helmet in limiting bacterial counts in the operating room during total joint arthroplasty. J Arthroplasty 1996;11(4):469e73. Friberg B, Friberg S, Ostensson R, Burman LG. Surgical area contamination e comparable bacterial counts using disposable head and mask and helmet aspirator system, but dramatic increase upon omission of head-gear: an experimental study in horizontal laminar air-flow. J Hosp Infect 2001;47(2):110e5. Pasquarella C, Pitzurra O, Herren T, Poletti L, Savino A. Lack of influence of body exhaust gowns on aerobic bacterial surface counts in a mixed-ventilation operating theatre. A study of 62 hip arthroplasties. J Hosp Infect 2003;54(1):2e9.
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39. Eisen DB. Surgeon’s garb and infection control: what’s the evidence? J Am Acad Dermatol 2011;64(5):960.e1e20. 40. Tanner J, Parkinson H. Double gloving to reduce surgical cross-infection. Cochrane Database Syst Rev 2006;3:CD003087. 41. Eckersley JR, Williamson DM. Glove punctures in an orthopaedic trauma unit. Injury 1990;21(3):177e8. 42. Whyte W, Hambraeus A, Laurell G, Hoborn J. The relative importance of routes and sources of wound contamination during general surgery. I. Non-airborne. J Hosp Infect 1991;18(2):93e107. 43. Ritter MA, French ML, Eitzen H. Evaluation of microbial contamination of surgical gloves during actual use. Clin Orthop Relat Res 1976;(117):303e6. 44. McCue SF, Berg EW, Saunders EA. Efficacy of double-gloving as a barrier to microbial contamination during total joint arthroplasty. J Bone Joint Surg Am 1981;63(5):811e3. 45. Misteli H, Widmer AF, Weber WP, Bucher E, Dangel M, Reck S, et al. Surgical glove perforation and the risk of surgical site infection. Arch Surg 2009;144(6):553e8 [discussion 558].
46. Junker T, Mujagic E, Hoffmann H, Rosenthal R, Misteli H, Zwahlen M, et al. Prevention and control of surgical site infections: review of the Basel Cohort Study. Swiss Med Wkly 2012;142:w13616. 47. Daeschlein G, Kramer A, Arnold A, Ladwig A, Seabrook GR, Edmiston Jr CE. Evaluation of an innovative antimicrobial surgical glove technology to reduce the risk of microbial passage following intraoperative perforation. Am J Infect Control 2011;39(2):98e103. 48. Fry DE, Harris WE, Kohnke EN, Twomey CL. Influence of double-gloving on manual dexterity and tactile sensation of surgeons. J Am Coll Surg 2010;210(3):325e30. 49. Gastmeier P, Sohr D, Schwab F, Behnke M, Zuschneid I, Brandt C, et al. Ten years of KISS: the most important requirements for success. J Hosp Infect 2008;70(Suppl. 1):11e6. 50. Mannien J, van den Hof S, Muilwijk J, van den Broek PJ, van Benthem B, Wille JC. Trends in the incidence of surgical site infection in the Netherlands. Infect Control Hosp Epidemiol 2008;29(12):1132e8.
Available online at www.sciencedirect.com
ScienceDirect The Surgeon, Journal of the Royal Colleges of Surgeons of Edinburgh and Ireland www.thesurgeon.net
Review
Surgical attire, practices and their perception in the prevention of surgical site infection S.M. McHugh a,*, M.A. Corrigan a, A.D.K. Hill a,b, H. Humphreys c,d a
Department of Surgery, Royal College of Surgeons in Ireland, Dublin 2, Ireland Department of Surgery, Beaumont Hospital, Dublin 9, Ireland c Department of Clinical Microbiology, Royal College of Surgeons in Ireland, Dublin 2, Ireland d Department of Microbiology, Beaumont Hospital, Dublin 9, Ireland b
article info
abstract
Article history:
Introduction: Clean surgical scrubs, surgical gowns and headgear are worn by operative
Received 16 September 2013
teams to decrease bacterial contamination and lower surgical site infection (SSI) rates.
Received in revised form
Methods: A detailed review was undertaken of peer-reviewed publications and other
10 October 2013
sources of material in the English language over the last 50 years included.
Accepted 10 October 2013
Results: Surgical scrubs should be clean and made of tightly woven material. Studies
Available online 20 November 2013
investigating single-use gowns and drapes versus reusable gowns report conflicting evidence. Double gloving may reduce SSI rates in procedures where no antibiotic prophylaxis
Keywords:
was administered. Bacterial contamination of the operative field has been shown to be
Surgical attire
decreased by the wearing of surgical headgear by the operating team.
Surgical site infection
Conclusions: Further consideration and better trials are required to determine the impact of
SSI
different theatre clothing on SSI rates.
Infection prevention
ª 2013 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.
Introduction Approximately 5% of patients undergoing surgery develop a surgical site infection (SSI).1 Patients who develop SSI are up to 60% more likely to spend time in an intensive care unit, five times more likely to be readmitted to the hospital, and twice as likely to die than are patients without an SSI.2 Furthermore, post-operative length of hospital stay is extended by 7e10 days leading to substantially increased overall care costs.2e7 Factors associated with SSI can be either intrinsic or extrinsic. Intrinsic patient factors are not reversible, such as diabetes mellitus. Extrinsic factors are those in which
adherence to best practice can decrease SSI.8 Standard procedures for the prevention of SSI include pre-operative patient preparation, appropriate prophylactic antibiotics, careful and skilled surgical technique, intra-operative medical management and post-operative surgical site or wound care.9e11 Practices in the operating theatre complex therefore should be considered as extrinsic factors. This is a restricted area with emphasis on the need for sterility and aseptic techniques compared with pathogen-residing areas such as hospital wards,12 with the use of clean surgical attire (i.e. scrubs, caps, masks, gloves and gowns) strictly regulated.9 Most surgeons have strong opinions on surgical attire,
* Corresponding author. Beaumont Hospital, Dublin 9, Ireland. Tel.: þ353 01 8093000. E-mail address: [email protected] (S.M. McHugh). 1479-666X/$ e see front matter ª 2013 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.surge.2013.10.006
48
t h e s u r g e o n 1 2 ( 2 0 1 4 ) 4 7 e5 2
although many are based on behaviour and ritual rather than evidence based medicine.13 In this article we review evidence based best practice with regard to surgical attire in the field of general surgery.
Methods A detailed literature review was undertaken through www. Pubmed.com and Google scholar (http://scholar.google.com). Surgical attire was defined as the wearing of clean surgical scrubs and footwear in the operating theatre complex and the wearing of surgical caps, masks, gowns and gloves for the operating team. Search terms used included “surgical attire”. “surgical scrubs”, “surgical site infection prevention”, “surgical masks”, “surgical caps”, “surgical gowns”, “surgical gloves”, “surgical shoes” and “surgical footwear”. Peerreviewed publications in the English language over the last 50 years were included, up to and including June 2013.
Results Surgical scrubs In current practice it is a widely held opinion of healthcare professionals that the wearing of clean surgical scrubs in restricted areas of healthcare facilities such as the operating theatre helps ensure cleanliness and reduces infections by limiting the introduction of microorganisms from healthcare personnel to the theatre environment.12,14 From the patient’s perspective, a study ascertaining their attitudes of the risks of cross-infection through healthcare workers attire has found that surgical scrubs are believed to be the most appropriate attire to prevent infection.15 While there has been no study demonstrating a direct link between non-sterile surgical attire and increased surgical site infections,13,14 the skin of staff working in the operating theatre is known to be a major source of bacteria dispersed into the air.16 Bacteria are dispersed on epithelial cells that break fragments of approximately 20 mm in size. Given that the interstices of standard cotton fabric have a pore size of 80 100 mm these fragments are small enough to pass through such fabrics. As such recent Association of Perioperative Registered Nurses (AORN) guidelines recommend that the scrub material should be tightly woven, as well as low-linting, stain resistant and durable.12 With regard to the wearing of surgical scrubs when leaving the theatre complex for a short period, e.g. to attend a multidisciplinary team meeting, a study by Copp et al. reported reduced levels of contamination on surgical scrubs when cover gowns were worn outside the operating room.17 Surgeons’ attitudes differ depending on speciality, with orthopaedic surgeons more likely to change to regular clothing when leaving the theatre complex compared with general surgeons.18 However, theatre nurses have been shown to be especially compliant with regulations restricting surgical attire outside the theatre complex.13,14,19,20 Guidelines issued by the then National Association of Theatre Nurses (now the Association for Perioperative Practice, AfPP) in the UK state
that the covering apparel worn when leaving the theatre complex must be a “clean single use gown or coat, completely secured by ties or button fasteners, which is worn once and then appropriately discarded”.20 The wearing of a white coat over surgical scrubs when leaving the operating theatre complex is controversial with some institutions advocating this practice but others arguing that pathogens living on scrub suits worn by healthcare personnel may still spread infection.14,21,22
Recommendations Surgical scrubs should be clean and made of tightly woven material. However, there is little research evidence to demonstrate that wearing surgical attire outside the theatre and returning to the theatre without changing into clean theatre suits increases SSI rates. In addition, there are no convincing studies demonstrating a relationship between the use of covering apparel and the prevention of infection. Nonetheless, given that surgical scrubs are used to minimise bacteria being shed by the operator, common sense dictates that surgeons should only leave the operating theatre complex when necessary, but when and if they do, they should cover the scrubs when outside the theatre complex or change in to new scrubs on returning to re-commence operating.
Surgical gowns As well as preventing bacteria from the skin of the operating team contaminating the sterile field, surgical gowns also fulfil the dual role of protecting the team from being contaminated by blood from the patient.13 In current clinical practice surgical gowns and drapes are fabricated from either multiple- or single-use materials. These two basic types of products each have advantages and disadvantages.23 With regard to reusable surgical gowns, there are two available types. The first is tightly woven polyester sheeting and the second a combination of fabrics laminated or coated with various types of films that provide increased protection.24 Single use surgical gowns consist of nonwoven materials such as spunlace hydroentangled material often consisting of wood pulp and polyester fibres. These are often in combination with materials that offer increased protection from liquid penetration such as plastic films.23e25 A number of previous studies have previously compared the use of reusable versus single-use gowns and drapes in the prevention of surgical site infection. A study by Moylan et al. involving 2181 general surgical procedures was performed to evaluated the effectiveness of a disposable gown and drape system versus a cotton system.26 The study end point was the development of SSI. They noted that the disposable spunlaced fibre system had a significantly lower overall infection rate (2.83% vs. 6.5%). However this study was not a randomised prospective trial. Garibaldi et al. in a comparative study took surgical site intra-operative swabs taken from the surgical site at time of skin closure. This study was a prospective randomised controlled trial (RCT). They noted no significant difference between procedures where reusable cotton gowns and drapes were used compared with nonwoven disposable material
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(15.5% vs. 13.1% p > 0.05). In addition post-operative SSI rates were not significantly different between the two groups.27 More recently a UK study randomised 505 patients undergoing coronary artery surgery in a single hospital over an 18month period to either a disposable, paper gown and drape system, or a reusable fabric system. There was no significant difference in the rates of sternal or leg SSIs between the two groups (p ¼ 0.87 and 0.62, respectively).28
Recommendations Current European standards recommend against the further use of cotton and polyester/cotton-blended drapes and surgical gowns.29 However given the conflicting evidence, additional larger and multi-centre studies using currently available single-use gowns and drapes versus reusable gowns will be required if difficult to fund and therefore conduct. Such studies would be prospective randomised controlled trials taking into account other variables such as antimicrobial prophylaxis.23
Surgical headgear In practice the wearing of disposable caps and masks in operating theatres have been recommended for scrubbed and non-scrubbed staff. Humphreys et al. studied the effect of surgical headgear on bacterial air counts in a sealed room, with and without ventilation. They found that the wearing of headgear was not associated with a reduction in air counts, and recommended that non-scrubbed staff in theatre no longer routinely wear headgear unless involved in a high risk surgical procedure such as the insertion of a prosthesis, as effective ventilation counteracts any increased bacterial shedding.30 A further UK study also used colony forming unit (cfu) measurement on settle plates placed at head and waist height in the operating surgeon and air samplers in the operating theatre to determine bacterial air count in ultraclean (enclosed vertical laminar-flow) and conventional (plenum ventilated) airflow theatres.31 In conventional theatres, the study reported a wide variation in colony counts, and no consistent benefit from surgical headgear was demonstrated. However in a laminar air-flow “ultra-clean” theatre there was 22 times the number of organisms on the settle plates when operating staff did not wear surgical headgear with no significant concurrent increase in air sample counts. Previous studies have suggested an increased degree of bacterial shedding on to the operative field when no facemask is worn. A study by Berger et al. assessed 30 cardiac catheterisation procedures. The number of bacterial colonies recoverable when no mask was worn was significantly higher than that detected when a full mask was worn (p < 0.002).32 This finding was echoed by a further study from the UK.33 Here a blood agar plate was placed 30 cm directly below the lips of 20 volunteers without a face mask for the first 5 min and then with a standard, soft pleated face mask for the subsequent 15 min. Analysis showed a significant reduction in the number of colonies cultured per plate when the mask was worn. A correlation with increased SSI rates has not, however, been previously demonstrated. A controlled, prospective
49
study of over 3000 patients recorded the incidence of SSI over a two-year period in general surgery. Results were statistically insignificant with the ‘masked’ operations having an infection rate of 4.7% compared 3.5% in those ‘unmasked’.34 Filtered exhaust helmets and gowns (space suits) have also been investigated predominantly in an orthopaedic setting with regard to efficacy in infection prevention. Previous reports noted a decreased SSI rate from 7.6% to 1.6% in orthopaedic surgery with the use of helmet aspirator systems and laminar airflow theatres.35 However control of concurrent SSIrelated variables has been lacking in previous studies, making support of such conclusions debatable.36 A more recent study comparing conventional cap and mask headgear with filtered exhaust helmets assessed air and surface contamination in 30 sham operations. They noted a 60-fold increase of bacterial sedimentation rate in the wound area when the filtered exhaust helmets were not used.37 However a 2003 study of 62 hip arthroplasties in 2003 noted that body exhaust gowns and headgear provided comparable protection to conventional attire in terms of numbers of colony forming units on settle plates in laminar airflow operating theatres.38
Recommendations Overall, conventional airflow theatres there is little evidence to suggest that the wearing of surgical facemasks or caps by non-scrubbed theatre staff reduces SSI rates. However, bacterial contamination of the operative field has been shown to be decreased by the wearing of surgical headgear by the operating team. Consideration must be given therefore in general surgical cases where grafts or prosthesis (i.e. synthetic vascular grafts) are being used to ensuring correct surgical headgear is appropriately worn.
Surgical gloves The use of gloves in surgery has evolved over time with early studies confirming a significant decrease in SSI with the use of gloves.39 Current debate centres on whether double gloving can reduce the risk of SSI. Double gloving has two purposes; to contribute to reduction in SSI through minimising contamination of the operative field arising from perforation and protecting the operative team from blood borne virus acquisition such as hepatitis B. A 2006 Cochrane review of 14 randomised controlled trials comparing double gloving versus single gloving found significantly more perforations in the single glove group than the inner gloves of the double glove group.40 The review found that the addition of a second pair of surgical gloves significantly reduced perforations of the innermost gloves. In addition, knitted outer gloves and glove liners also significantly reduce perforations to the innermost glove. Perforation indicator systems such as the wearing of coloured inner gloves were also seen to result in significantly more innermost glove perforations being detected during surgery. It has been traditional teaching that gloves should be changed promptly if punctured.41 However, there has not been a study conclusively demonstrating an increased risk of SSI associated with glove punctures intra-operatively. In fact several studies have demonstrated no increase in bacterial contamination of the surgeons’ hands on the outside of the
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Table 1 e Summary of contentious issues, evidence and recommendations. Contentious issues
Evidence
Wearing scrubs outside of the operatingtheatre complex
No randomised controlled trials. Best practice recommendations from AfPP
The use of reusable versus single-use gowns and drapes in the prevention of surgical site infection
Two RCTs. Prospective, non-randomised study. Best practice recommendations from CEN
The wearing of facemasks and caps decreases SSI rates
Studies of settle plates in the surgical field. Nonrandomised clinical prospective study of >3000 patients Cochrane review of 14 RCTs. Two prospective cohort studies of >10,000 patients
Double gloving reduces SSI rates
surgical gloves during operations when gloves were shown to be punctured.42e44 One such study involving patients undergoing biliary surgery noted no transfer of skin bacteria from the operating team through the perforated gloves to the operative field.42 Similarly, both Ritter et al.43 and McCue et al.44 demonstrated that areas of contamination on surgical gloves examined after the procedure did not correspond with glove puncture locations in gloves that had been perforated. Despite these findings a more recent study from a team of Swiss researchers has linked glove perforation with increased SSI rates.45 This was a prospective cohort study involving 4147 surgical procedures. Multivariate analysis showed an increased risk of SSI in procedures where there was glove perforation and when antibiotic prophylaxis had not been administered (odds ratio 4.2 p ¼ 0.003). When antibiotic prophylaxis was used the incidence of SSI was not significantly increased in cases where gloves were punctured. This finding was lent further weight by a 2012 study of 6283 consecutive general surgical procedures followed for a one year period. Here glove perforation in the absence of systemic antibiotic prophylaxis was also found to significantly increase the risk of SSI (OR 2.0; CI 1.4e2.8; p < 0.001).46 This raises the potential importance of double gloving in reducing SSI only in cases where antibiotic prophylaxis has not been routinely administered (i.e. clean procedures), when it is inadvertently omitted or given at an inappropriate time, e.g. after the initial incision. Gloves impregnated with antimicrobials represent a novel approach to decreasing contamination after glove perforation. A recent study assessed microbial passage between glove layers in those wearing single gloves, double gloves and antimicrobial trilayer gloves. A significant reduction in microbial passage was noted in those wearing trilayer antimicrobial gloves.47 Wearing a third layer of sterile gloves itself has previously been reported to decrease glove perforation rates.40 However while double gloving has been reported to have no substantial impact on function or tactile sensitivity in
Conclusions
References
Theatre staff should wear a single use cover gown or coat which should be discarded when returning to the theatre complex Decreased SSI rate in single use gowns in non-randomised study. Randomised trials demonstrated no significant difference. European standards recommend single use gowns and drapes Little evidence to suggest that the wearing of surgical facemasks and caps reduces SSI rates. Bacterial contamination of the operative field has been shown to be decreased Double gloving reduces glove perforation rate. Double gloving may reduce SSI rates in procedures where antibiotic prophylaxis is not given.
14,20e22
26e29
31e34
40,45,46
surgeons,48 wearing a third layer of gloves may compromise surgical dexterity.
Recommendations Double gloving has been shown to decrease glove perforation rates. However, debate remains as to whether increased glove perforation rates lead to increased SSI incidence. Recent studies suggest that double gloving reduces SSI risk in clean procedures where antibiotic prophylaxis is not used without compromising manual dexterity of the surgical team.40 Double gloving is also recommended to decrease the risk of occupational acquisition of a blood borne virus such as hepatitis B when the operation involves a bloody field and there is glove perforation with or without an injury to the operator.
Conclusions There exists on-going debate about the efficacy of different aspects of surgical attire such as double gloving to decrease SSI rates (Table 1). The wearing of clean surgical scrubs, surgical gowns and headgear for operating teams helps decrease bacterial contamination. Double gloving decreases the glove perforation rate, which may impact on SSI rates in cases where antibiotic prophylaxis is not given. In a general sense the donning of surgical attire helps to demarcate the operating theatre complex from the rest of the hospital indicating a separate but high risk zone requiring extra efforts in asepsis to prevent infection. By making theatre personnel change to specific surgical scrubs, shoes and hats before entering the theatre complex, this ritualistic behaviour serves as a daily reminder of the importance of sterility and infection prevention practices in the operating theatre. Further work is required to determine the impact of theatre clothing on SSI rates as its unnecessary use represents a significant cost and an environmental issue in terms of disposal. However, RCTs in multiple centres as would probably be
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required to address these questions are probably not feasible. Data could be collected from many national surveillance programmes of SSI as exist elsewhere such as in the Netherlands and Germany on practices.49,50 This information could be collated with SSI rates to determine the impact of surgical attire on infection rates, while allowing for risk factors and case mix.
references
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