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Key Points

Question听 Is the combination of surgical jackets and bouffants in the operating room effective in reducing the risk of surgical site infection?

Findings听 In this cohort study of 34鈥�042 inpatient surgical cases at a large tertiary care academic institution, there was no significant difference in surgical site infections following the mandate of surgical jackets and bouffants.

Meaning听 Institutions should evaluate their own data to determine whether recommendations by outside governing organizations are beneficial and cost-effective.

Importance听 Surgical site infections (SSIs) are associated with increased morbidity and mortality. Various measures have been enacted decrease the occurrence of SSIs involving the regulation of the attire worn by the operating room staff, at times without sufficient peer-reviewed literature to support their implementation.

Objective听 To evaluate whether the combination of mandated surgical jackets and bouffants in the operating room is associated with the risk of surgical site infection.

Design, Setting, and Participants听 A retrospective cohort study of 34鈥�042 inpatient surgical encounters at a large academic tertiary care hospital was performed. Three periods between January 2017 and October 2018 were compared, corresponding with implementation of surgical jackets and the subsequent mandate of surgical jackets plus bouffant head covers. All inpatient surgical cases were included from University of Alabama at Birmingham University Hospital, a single-center, large academic tertiary care hospital. The study comprised a consecutive sample of all inpatient surgical cases over a 22-month period.

Exposures听 No surgical jackets or bouffants mandated (8 months), surgical jackets mandated (6 months), both surgical jackets and bouffants mandated (8 months).

Main Outcomes and Measures听 The primary study outcome was SSIs, which were collected from institutional infection control monthly summary reports, according to the National Healthcare Safety Network definitions for superficial incisional, deep incisional, and organ/space SSIs. Secondary outcomes included wound dehiscence, postoperative sepsis, death, and cost of interventions.

Results听 A total of 34鈥�042 inpatient surgical encounters cases were included in the analysis over the 22-month study period. Of the total patients, 16鈥�380 were women (48%) and 17鈥�638 were men (52%). There was no significant difference in the risk of SSI (1.01% vs 0.99% vs 0.83%; P鈥�=鈥�.28), mortality (1.83% vs 2.05% vs 1.92%; P鈥�=鈥�.54), postoperative sepsis (6.60% vs 6.24% vs 6.54%; P鈥�=鈥�.54), or wound dehiscence (1.07% vs 0.84% vs 1.06%; P鈥�=鈥�.20) between the 3 groups. Receipts from the first 6 months of the 2018/2019 fiscal year provided an estimated expenditure of more than $300鈥�000 annually on surgical jackets. Bouffants were found to be less expensive than surgical skull caps.

Conclusions and Relevance听 The results of this study suggest that surgical jackets and bouffants are neither beneficial nor cost-effective in preventing SSIs. Institutions should evaluate their own data to determine whether recommendations by outside governing organizations are beneficial and cost-effective.

Surgical site infections (SSIs) are a difficult problem for both patients and surgeons and are associated with increased morbidity and mortality.^1,2 It is estimated that there are as many as 300鈥�000 SSIs annually in the United States.³ These infections account for approximately 20% of all hospital-acquired infections and increase hospital length of stay by a mean of 9.7 days.^4,5 The economic consequence of these infections is estimated to be as high as $10 billion annually in the United States alone.⁶ Additionally, patients who develop an SSI have up to an 11 times higher risk of mortality compared with those who do not.⁷ Therefore, implementing SSI prevention measures in any surgical setting is the first line of defense in reducing the incidence of this complication.

Various measures have been enacted to decrease the occurrence of SSIs involving the regulation of the attire worn by the operating room (OR) staff. The Association of Perioperative Registered Nurses (AORN) made several recommendations in 2015⁸ regarding appropriate surgical attire. One notable recommendation for a 鈥渃lean surgical head cover or hood that confines all hair and completely covers the ears, scalp skin, sideburns, and nape of the neck鈥� has led to the transitioning from a surgical skull cap to an alternate head covering, such as a bouffant or hood, in many institutions.^8,9 Additionally, the AORN advocated that all personnel present in the OR and not scrubbed wear surgical jackets to cover their arms at all times. The joint commission and other accrediting bodies have begun to enforce these recommendations as regulations, citing hospitals for poor infection control practice if they discovered that surgical caps were being worn in the OR.¹⁰

Some evidence exists in support of certain OR attire mandates in the prevention of SSI, such as the use of gloves and impermeable surgical gowns, but there is little information regarding the association of surgical jackets and bouffants with infections.¹¹ Shallwani et al¹² compared infection rates before and after the implementation of bouffant head coverings and found a nonsignificant increase in infection rates with bouffants. A similar study found no difference in the rates of SSI with and without the use of bouffant head coverings.¹³ Chow et al¹⁴ evaluated the implementation of surgical jackets and reported no difference in SSI rates. To our knowledge, no study has evaluated whether the combination of bouffants and surgical jackets is associated with the risk of SSI. This study sought to test the hypothesis that the risk of SSI is not associated with the use of bouffants and surgical jackets.

After obtaining institutional review board approval from the University of Alabama at Birmingham, data from all inpatient surgical cases at a large academic tertiary care hospital between January 1, 2017, and October 31, 2018, were collected. The University of Alabama at Birmingham institutional review board granted a waiver of patient consent for this project owing to the volume of patients whose medical records would be retrospectively reviewed. All surgical specialties at our institution were included. The time was split into 3 groups based on changes in hospital policy regarding mandatory OR attire (Figure 1). Quiz Ref IDThe first period when neither bouffants nor surgical jackets were required was from January 1, 2017, to August 31, 2017. The second period when only surgical jackets were required was from September 1, 2017, until February 28, 2018. Finally, the third period began when bouffants were required, starting in March 2018. The periods for each group lasted 8, 6, and 8 months, respectively. Order invoices for surgical jackets, bouffants, and surgical caps were obtained to provide clear dates of when each was implemented in the OR in addition to providing cost information.

The main outcome of interest was SSIs, which were collected from our institutional infection control monthly summary reports. Surgical site infections at our institution are identified and recorded according to the National Healthcare Safety Network definitions for superficial incisional, deep incisional, and organ/space SSIs.⁵ Secondary outcomes included wound dehiscence, postoperative sepsis, and death among surgical inpatients, defined based on International Statistical Classification of Diseases and Related Health Problems, Tenth Revision codes. Patient comorbidities and procedure characteristics were also extracted. These included age, sex, length of stay, average case duration, American Society of Anesthesiologists class, prolonged intubation, chronic steroid use, presence of rheumatoid disease, chronic kidney disease, chronic obstructive pulmonary disease, hypoalbuminemia, liver disease (chronic hepatitis C, cirrhosis, and hepatic failure), increased body mass index (鈮�30; calculated as weight in kilograms divided by height in meters squared), diabetes, tobacco use, requirement of blood transfusion during hospitalization, transfer to intensive care unit, and hospital-associated conditions that did not involve SSIs (foreign object retained, air embolism, blood incompatibility, pressure ulcer, catheter-associated urinary tract infection, vascular-catheter鈥揳ssociated infection, poor glycemic control, deep vein thrombosis/pulmonary embolism, and iatrogenic pneumothorax).

The proportion of patients who experienced SSIs, wound dehiscence, postoperative sepsis, and death were compared between the 3 groups using a 蠂² test. Additionally, potentially confounding patient and procedure characteristics were similarly compared between the 3 groups using 蠂² and t tests. Variables demonstrating statistically significant differences between the groups were used to adjust the temporal comparisons in the outcomes using logistic regression. A P value of less than .05 was considered statistically significant, and the P value was 2-sided.

A total of 34鈥�042 inpatient surgical encounters were included in the analysis over the 22-month study period. The overall SSI risk was 0.94% and the overall mortality, postoperative sepsis, and wound dehiscence risks were 1.92%, 6.48%, and 1.01% respectively. There was no significant difference in the risk of any outcome over time (Table 1). Quiz Ref IDAdditionally, the SSI risk did not decrease significantly throughout the duration of the study (Figure 2).

There were 4 potentially confounding variables that differed statistically among the 3 groups: presence of rheumatoid disease, chronic steroid use, poor glycemic control, and American Society of Anesthesiologists class (Table 2), although adjusting for these variables had minimal effect on the difference in the SSI risk over time.

Quiz Ref IDHospital ordering receipts for the 2017/2018 fiscal year identified $264鈥�760.78 spent on purchasing surgical jackets during the 14 months of the second and third groups. Jackets were purchased for $2.06 per unit for the standard large size ($20.59 for a pack of 10), although cost did increase with larger sizes. Additionally, receipts for the first 6 months of the 2018/2019 fiscal year provided an estimated expenditure of more than $300鈥�000 annually on surgical jackets. Quiz Ref IDBouffants were found to be 57.14% less expensive than surgical skull caps. Bouffants cost $0.04 per unit ($2.72 for a box of 75) while surgeon caps cost $0.07 per unit ($7.44 for a box of 100).

Surgical site infections place a significant financial burden on the health care system and are a common cause of morbidity and mortality for patients. Prevention of SSIs is of great importance to all members of the health care team. Regulatory bodies have suggested that OR personnel cover their arms with surgical jackets and wear a 鈥渃lean surgical head cover or hood that confines all hair and completely covers the ears, scalp skin, sideburns, and nape of the neck.鈥�⁸ Although not explicitly stated, this has been understood by many institutions as a recommendation for bouffants and against surgical caps in an effort to decrease the risk of SSIs.⁸ Our data add support to the growing body of literature suggesting that these well-intentioned regulations have not been shown to have an effect on SSIs.

Covering the arms of OR personnel with surgical jackets or other long sleeves has become a controversial topic over the last decade owing to conflicting recommendations among governing organizations. The rationale behind wearing surgical jackets in the OR is to decrease the shed of bacteria from the arms. This theoretical benefit has been studied by multiple groups and has been demonstrated not to decrease the risk of SSIs or bacterial colonization. Interestingly, this policy is in direct contradiction to the United Kingdom鈥檚, where they instituted a policy in 2007 that restricts any clothing or accessories extending beyond the elbow.¹¹ Older studies have shown that completely unclothed surgeons shed only a fraction of the number of bacteria compared with those wearing scrubs or street clothes, which seems to support this 鈥渂are below the elbow鈥� policy.^15-17 In 2016, Chow et al¹⁴ investigated the rate of SSIs 1 year prior to and 1 year following the institution of a policy mandating cover jackets in the OR. They not only found no significant difference in SSI rates, but their data actually trended toward an increase in SSI rates during the time in which OR jackets were worn. Quiz Ref IDOur study showed similar results, with no significant difference in SSI rates. The 2019 AORN updated guidelines¹⁸ regarding surgical jackets state 鈥渘o recommendation can be made for wearing long sleeves in the semi-restricted and restricted areas other than during performance of preoperative patient skin antisepsis,鈥� stating further research would be needed to evaluate harms and benefits.¹⁸

Similarly, the recommendations regarding surgical head coverings were implemented to cover the ears and decrease the likelihood of bacterial shed to the sterile field. The rationalization stemmed from the idea that this would decrease the release of airborne bacteria into the OR; however, this has not been shown to correlate with increased SSI rates. In a study comparing SSIs in cases of surgeons wearing bouffants vs skull caps, no significant differences were found when adjusting for the type of operation.¹⁹ Shallwani et al¹² demonstrated no difference in infection rates in neurosurgery cases 1 year after the implementation of bouffants. While the 1999 US Centers for Disease Control and Prevention guidelines strongly recommend the use of caps or hoods in the OR to fully cover the hair on the head and face, no specific headwear was clearly identified in the guidelines or supported by prior literature.²⁰ Interestingly, one article²¹ that took a more basic science approach to this issue found that bouffants were more permeable and had greater microbial shed than skull caps, concluding that bouffants 鈥渟hould not be considered superior to skull caps in preventing airborne contamination in the OR.鈥�²¹

While our study did not evaluate bouffants individually, we did find that the combination of bouffants and jackets did not appear to decrease infection risk. The most recent guideline, published in July 2019, presents a new stance in regard to recommendations about surgical head coverings, as the recommendation that all hair must be 鈥渃ompletely covered鈥� has been removed.¹⁸ They also redact their stance on requiring the ears to be covered, because although the ears have been shown to be a 鈥減otential reservoir for pathogens,鈥� this has not been shown to play a role in the development of SSI.²² In a draft of the guidelines, which prompted a response by the American Society of Anesthesiologists, there was a recommendation that head covering choice should be at the discretion of the surgical team 鈥渂ased on the patient鈥檚 risk for developing a surgical site infection and the team member鈥檚 risk of exposure to blood, body fluids and other potentially infectious materials.鈥�²³ This recommendation was criticized and later removed from the final published guidelines owing to the lack of available evidence to associate surgical headwear and SSIs.

To our knowledge, there is no evidence that has shown an association between SSIs and certain OR attire, with the exception of sterile gowns and gloves.¹¹ As health care costs continue to increase, we must be cognizant of the cost associated the implementation of these regulations. During the 2017/2018 fiscal year, our institutional expenditures for surgical jackets alone totaled more than $264鈥�000. Bouffants did not have as much of a financial impact and were found to be slightly less expensive than skull caps. A 2019 study²⁴ showed that the cost of attire for one person entering the OR increased from $0.07 to $0.12 to $1.11 to $1.38 after the implementation of the AORN attire policy. The authors estimated that the use of surgical jackets alone in all US hospitals would cost the health care system $540 million annually. The literature appears to demonstrate that no difference in surgical infection rates occur with the use of surgical jackets and bouffants, but result in a substantial cost to the health system.

We acknowledge several limitations to our study. Although we evaluated many patient demographics and comorbidities to ensure the groups were relatively homogeneous, there were some comorbidities that were not extracted from our institutional database, including surgical specialty/case type and complexity/acuity of cases. However, there is little reason to believe that these characteristics would have meaningfully changed during the study period. While the mandates of surgical jackets followed by bouffant head covers were hospital policy and strictly enforced by OR staff, the numeric degree of compliance was unable to be determined, which is a limitation of our study. Additionally, we were not able to control for differences, such as skin preparation techniques, across different surgeons. For example, surgeons often prefer to use a varying number of preparation sticks or different solutions. Finally, there have been recorded seasonal differences in infection rates that may have affected the study, which we could not control owing to the temporal nature of the implementations of different attire regulations at our institution.²⁵

The SSI risk remained relatively constant throughout the duration of the study. There were no significant differences in the risk of SSIs, postoperative mortality, sepsis, and wound dehiscence between the 3 study periods. Therefore, the results of this study suggest that surgical jackets and bouffants are neither beneficial nor cost-effective in preventing SSIs. The results add to the growing body of research that there is no clear benefit to bouffants and surgical jackets in the quest to decrease the incidence of SSIs. Ultimately, institutions should evaluate their own data to determine whether recommendations by outside governing organizations are beneficial and cost-effective.

Corresponding Author: Brent A. Ponce, MD, University of Alabama at Birmingham, 1313 13th St S, Ste 203, Birmingham, AL 35205 (bponce@uabmc.edu).

Accepted for Publication: December 1, 2019.

Published Online: February 12, 2020. doi:10.1001/jamasurg.2019.6044

Correction: This article was corrected on May 27, 2020, to fix the accepted for publication date.

Author Contributions: Dr Ponce had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Wills, Smith, McGwin, Ghanem, Ponce.

Acquisition, analysis, or interpretation of data: Wills, Smith, Arguello, McGwin, Ponce.

Drafting of the manuscript: Wills, Smith, Arguello, McGwin, Ghanem.

Critical revision of the manuscript for important intellectual content: Wills, Smith, Arguello, McGwin, Ponce.

Statistical analysis: Smith, McGwin.

Administrative, technical, or material support: Wills, Smith, Arguello, Ponce.

Supervision: Wills, Smith, McGwin, Ghanem, Ponce.

Conflict of Interest Disclosures: Dr Ponce has stock or stock options in Help Lightning, is a pain presenter/speaker and paid consultant for Tornier, and receives IP royalties from Wright Medical Technology Inc. No other disclosures were reported.

Additional Contributions: We thank Yvonne Chodaba, MD, for her assistance with demonstrating the surgical attire groups in Figure 1 and granting permission to publish this information.