Surgical Attire Debate Continues as Experts Weigh the Evidence

Common sense dictates that limiting surgical patients' exposure to any reservoir that could harbor pathogenic organisms could help prevent surgical site infections (SSIs). Wearing proper surgical attire is a cornerstone of SSI prevention, yet there has been strident disagreement on some of the finer points of surgical attire and its impact on SSI rates. Worse yet, a recent paper demonstrated that implementation of stringent operating room attire policies does not reduce SSI rates.

Farach, et al. (2018) describe how two teaching hospitals imposed strict regulations on operating room (OR) attire, including full coverage of ears and facial hair, with the researchers hypothesizing that this intervention would reduce superficial SSIs. They compared NSQIP data from all patients undergoing operations in the nine months before implementation (n = 3,077) to time-matched data nine months post-implementation (n = 3,440). The researchers report that, "Despite a shift toward more clean cases, there were more SSIs post-implementation (33 vs 30). There were no differences in length of stay, complications, or mortality between the two time periods. Overall, SSI increased with wound class: 0.6 percent, 0.9 percent, 2.3 percent, and 3.8 percent in clean, clean-contaminated, contaminated, and infected cases, respectively. Limiting the review to clean or clean-contaminated cases, incisional SSIs increased from 0.7 percent (20 of 2,754) to 0.8 percent (24 of 3,115) (p = 0.85). A multivariable analysis showed that implementation of these policies was not associated with decreased SSIs. The largest predictors of SSIs were preoperative infection, operative time >75th percentile, open wounds, and dirty/contaminated wounds. A hypothetical analysis revealed that a sample size of 485,154 patients would be required to demonstrate a 10 percent SSI reduction among patients with clean or clean-contaminated wounds."

Farach, et al. (2018) note that, "Although a number of SSI prevention recommendations were made about preoperative, intraoperative, and postoperative practices among these infection-control guideline statements, there were no recommendations specific to surgical attire until 2015, when the Association for Perioperative Registered Nurses (AORN) published their updated recommendations on operating room attire. These included stringent policies designed to minimize the exposed areas of skin and hair of operating room staff, stating that, 'personnel entering the semi-restricted and restricted areas should wear a clean surgical head cover or hood that confines all hair and completely covers the ears, scalp, skin, sideburns, and nape of the neck.' Since 2015, regulatory and accrediting bodies have enforced the AORN's recommendations. However, these new attire policies have been met with much criticism, as there is no direct scientific evidence to support their recommendations. In fact, although these recommendations were made with the intent of reducing the risk and incidence of SSIs, the recent AORN-sponsored literature review of surgical head coverings repeatedly stated that there is 'no conclusive evidence that hair covering prevents SSI,' and in the original guideline statement, many of the recommendations are noted to be made based on pseudoscientific data."

Chiming in on the issue are Kothari, et al. (2018), who observed, "The American College of Surgeons guidelines indicate that skull caps are acceptable, and the Association of Perioperative Registered Nurses recommends bouffant caps. However, no scientific evidence has shown a significant advantage in SSI reduction with either cap." The researchers sought to determine the influence of surgical cap choice on SSIs, and analyzed data from a previously published prospective randomized trial on the impact of hair clipping on SSIs. Patients were grouped by the attending surgeons' preferred cap choice into either bouffant or skull cap groups.

Overall, 1,543 patients were included in the trial. Kothari, et al. (2018) found that, "Attending surgeons wore bouffant caps in 39 percent and skull caps in 61 percent of cases. Prevalence of diabetes and tobacco use were similar between the groups. Bouffant caps were used in 71 percent of colon/intestinal cases, 42 percent of hernia/other cases, 40 percent of biliary cases, and only 1 percent of foregut cases. Overall, SSIs occurred in 8 percent and 5 percent of cases with a bouffant and skull cap, respectively; with 6 percent vs. 4 percent classified as superficial, 0.8 percent vs. 0.2 percent classified as deep, and 1 percent vs. 0.9 percent classified as organ space; however, when adjusting for the type of operation, no significant differences in SSI rates were observed for skull caps vs. bouffant caps." The researchers concluded that, "Attending surgeon preference for bouffant vs skull cap does not significantly impact SSI rates after accounting for surgical procedure type. Future guidelines should consider these clinical outcomes data and surgeon preference should dictate operating room headwear."
As debate continues around the wearing of surgical caps or bouffants, AORN's new guideline will reflect the latest study and recommend facilities determine the appropriate attire based on practice and specialty.

Lisa Spruce, DNP, RN, CNS-CP, CNOR, ACNS, ACNP, FAAN, director of evidence-based perioperative practice for AORN, recently reviewed the significant changes contained in the new surgical attire guideline, which will be available online July 1, 2019. Let's review the most pertinent points.

Regarding laundering of surgical attire, Spruce pointed out that AORN maintains its stance on home laundering. "We are not approving home laundering because it is not monitored for quality, consistency or safety," Spruce says. "Studies showed us that scrubs become contaminated throughout the work day and bacteria can be transmitted to the environment. Some of these organisms can survive home laundering, can cause biofilm formation in the home washing machine and can transfer that bacteria to other clothes washed in the home washing machine. What we don't know is whether this scrubs contamination can contribute to healthcare-associated infections (HAIs), but it is a concern and we also know that the water in our home washing machines just doesn't get hot enough to kill those microorganisms.
Spruce adds, "We want you to wear clean surgical attire when you are entering semi-restricted and restricted areas, but after each daily use, we want you to launder your scrub attire." If laundering at a healthcare-accredited laundry facility or at a healthcare institution's laundry, then home-laundering will be necessary, but with a caveat. "If you are going to home-launder, you must provide guidance to your employees for home laundering," Spruce says. "It is important to read the guideline; there are studies in it that will provide guidance. Even though we aren't recommending home laundering, it will help you with that process."

Spruce added that AORN recommends that surgical team personnel remove scrub attire before leaving the healthcare institution. "The benefits of removing surgical attire before leaving the facility outweighs the harms," Spruce says. "Moderate-quality evidence here supports changing out of surgical attire into street clothes when leaving the building, to reduce the potential of healthcare workers to transport potentially pathogenic microorganisms from the facility into your home or community.  A systemic review concluded that provider attire is a potential source of pathogenic material transmission; there is limited data on the role of attire in HAIs but the authors did recommend that healthcare workers wear clean clothes when returning and exiting the facility." 

Regarding personal clothing, Spruce says AORN does not offer any recommendation for clothes worn under scrub attire. "When you see these no-recommendation statements, you will need to establish and implement a process for managing personal clothing that may be worn under your scrub attire," she advises. "That includes the type of fabrics, such as a non-linting fabric, the amount of fabric allowed, such as a turtleneck allowed under a V-neck, or a T-shirt that hangs down on the arms, as well as laundering frequency (for example, frequency and method of laundering). Any personal clothing that is worn that becomes contaminated with blood, body fluid or other potentially infectious material (OPIM), must remain at the healthcare facility for laundering; that is a regulatory requirement."
Spruce continues, "Fabrics that are worn in the operating room should be tightly woven and low-linting, but we cannot make a recommendation for wearing surgical attire made of antimicrobial fabric, and this is a change to the guideline. Although the evidence regarding antimicrobial scrub attire was high-quality, there was a wide range of variability in the study results and several studies were performed in the laboratory setting. There is no research to determine the potential harm to the wearer, of wearing surgical attire made from antimicrobial fabric, so that is a gap we need more evidence on. If you want to consider this, you should follow your healthcare organization's process for the pre-purchase evaluation of products when considering purchasing antimicrobial scrubs."

AORN recommends that if cover apparel is worn, it should be clean. Spruce reports that the evidence around cover apparel was of moderate quality, and it showed that lab coats worn as cover apparel can be contaminated with large numbers of pathogenic microorganisms. Researchers also found that cover apparel is not always discarded daily after use or laundered daily.

Regarding head coverings, the recommendation is to cover the scalp and hair when entering the semi-restricted or restricted areas of the OR. "This section is a big change from the previous guidelines and you will want to read this carefully," Spruce advises. "We know that wearing a head covering may contain hair and bacteria that is shed by our team members, which may prevent contamination of the sterile field and reduce the patient risk for SSIs. But research has not demonstrated that covering the hair affects the multi-factorial outcome of SSI rates. There are case studies that demonstrated that human-to-human bacteria shed from the scalp and hair of operative team members has been directly attributed to SSI outbreaks; however, these case studies are old, there have been no recent case reports of this, so the recommendation is just cover your hair."

Spruce continues, "You must keep in mind that we have no recommendation for the type of head covers worn in semi-restricted or restricted areas. The evidence does not demonstrate any association between the type of head covering or extent of hair coverage in the outcome of SSI rates. You are going to need to form an inter-disciplinary team, including members of the surgical team and infection preventionists, to determine the type of head covers will be worn at your organization. Please read the evidence before determining this. No recommendation can be made for covering the ears in semi-restricted or restricted areas. Moderate-quality evidence does suggest that ears are a potential reservoir for pathogens; however, research has not demonstrated any association between covering the ears and SSI rates. We also know that covering the ears may have potential harms such as causing impaired hearing, which could potentially interfere with important team communication, interfere with the use of stethoscope, and hinder the fit of protective eyewear. If you are going to allow the wearing of cloth head coverings, you must establish a process for the type of fabrics that you will allow in your setting, the laundering frequency, and the laundering method. Are you going to facility-launder them or have them home-laundered? Read the section on head coverings thoroughly to help you write any policies."
Another change to the recommendations involves beards; AORN recommends covering beards in restricted areas and while preparing and packaging items in the clean assembly section of the sterile processing area.

Yet another change addresses shoes. "We want you to wear clean shoes when entering the semi-restricted or restricted area," Spruce says. "Now, the definition of clean we have in our guideline is that it is the absence of visible dust, soil, debris or blood. There was a systematic review that found shoes have the ability to transfer infectious organisms to the floor and contribute to floor contamination. You'll want to keep that in mind if you wear your shoes from the perioperative area to your home; you could be contaminating your home floor; you also want to wear protective footwear that meets your healthcare organization's requirements."

Regarding identification badges, Spruce notes, "They are part of your attire and you want to clean them with a low-level disinfectant when it becomes soiled with blood, body fluids or OPIM. There are quite a few studies with moderate-quality evidence supporting that ID badges may be contaminated with pathogens and need to be cleaned. You will need to determine the frequency of ID badge cleaning and disinfection; for example, daily, weekly and any time you see visible soil. You also want to clean your lanyards; the previous guideline said cloth lanyards should not be worn, but you can wear a lanyard if it can be cleaned with a low-level disinfectant when it becomes soiled with blood, body fluids or OPIM. Be sure you are cleaning those on a routine basis and they are made from a material that can be cleaned."

Spruce continues, "Forever and ever we were not supposed to wear stethoscopes around our necks; however, that has been removed from the guideline; the recommendation is to clean stethoscopes before each patient use according to the manufacturer's instructions for use. Moderate-quality evidence supports it, and it is also all about hand hygiene, which decreases the risk of transmitting pathogens to patients and environmental surfaces. Stethoscopes come in direct contact with patient skin and could be a mechanism for transmitting pathogens from that patient to other patients, from the patient to the healthcare worker, or from healthcare worker to patient. So, any time you use that stethoscope, you clean it before use."

A conditional recommendation is to establish a process to prevent contamination of the semi-restricted and restricted areas of the OR through the introduction of personal items -- such as purses, briefcases and backpacks, -- into the operating theater. "This process may include cleaning them, or containing the item, or placing the item in a designated location," Spruce explains. "These items that people bring into the OR can be difficult to clean, they also may harbor pathogens and cleaning them helps to decrease the transmission of potentially pathogenic microorganisms from external sources to perioperative surfaces and vice versa. You're going to need to establish the process of how you are going to handle personal items, deciding what works best for your facility. Now, when we talk about cell phones, tablets and other personal communication electronic equipment and devices, this is a recommendation for you to clean those according to manufacturers' instructions for use before you bring them into the operating room and perform hand hygiene. Moderate-quality evidence demonstrated that these items are highly, highly contaminated with microorganisms, some potentially pathogenic; you want to make sure you are cleaning them. It is critical to perform hand hygiene after any cleaning; those two things together are very important."

This guideline is only available in AORN's facility reference center on its website beginning July 1, 2019. This guideline will not be published in book form until January 2020.

Conflict Over Surgical Attire Guidance
Even as a nursing organization educates around its soon-to-be released updated guideline on surgical attire, a medical society calls its stance into question, causing practitioners to re-evaluate what they think they know about preventing surgical site infections (SSIs).

A paper by Elmously and Gray (2019) recently explored the effectiveness of surgical attire worn during operative and other invasive procedures as one of the mechanisms that may assist in preventing SSIs. However, AORN asserts that the paper misrepresented the AORN recommendation throughout the article. In a letter to Timothy J. Eberlein, editor-in-chief of the Journal of the American College of Surgeons, Lisa Spruce of AORN noted, "The authors state, 'The guidelines ban the traditional surgeon skull cap, mandate the use of a bouffant cap…' This is unequivocally incorrect. The guideline does not mention skull caps nor is there any mention of bouffant caps; AORN has neither urged the elimination of traditional surgical caps nor mandated the use of bouffant caps. AORN does not specify the type or style of head covering that should be worn. Recommendation III of the guideline states, 'A clean surgical head cover or hood that confines all hair and completely covers the ears, scalp skin, sideburns, and nape of the neck should be worn.' Additionally, it is standard practice that if the AORN guidelines are going to be discussed then the guideline itself should be cited and not secondary references."

Spruce also points out that Elmously and Gray stated, "the main criticism (of the guideline) being that, although well intentioned, there is little evidence to support them, and they were promulgated without collaboration with the surgical community especially in light of multiple studies showing no relationship between headgear and SSIs." In her letter, Spruce counters, "Again this is incorrect. The AORN guidelines are based on a comprehensive, systematic review of research and non-research evidence; the individual references are appraised and scored, and the recommendations are rated according to the strength and quality of the evidence supporting each recommendation. The guidelines are authored by AORN perioperative practice specialists and in collaboration with liaisons representing the American Association of Nurse Anesthetists, the American College of Surgeons, the American Society of Anesthesiologists, the Association for Professionals in Infection Control and Epidemiology, the International Association of Healthcare Central Service Materiel Management, and the Society for Healthcare Epidemiology of America. The recommendations in the Guideline for Surgical Attire include a benefits balanced with harms assessment to determine the risk/benefit of recommendations to patients. The recommendations are not based on a proven causal effect of a relationship between headgear and SSIs but a benefit to patients because hair and skin can harbor bacteria that can be dispersed into the environment and the purpose of covering them is to reduce the patient’s exposure to potentially pathogenic microorganisms from the perioperative team member’s head, hair, ears, and facial hair."

Spruce added that in a table accompanying the Elmously and Gray article, the authors state that AORN recommends “Arms should be covered with long-sleeved jackets in semi-restricted areas” and that “Non-disposable head coverings should be covered with a disposable head cover.” Spruce says that neither is recommended by AORN and clarifies further, "For arm covering the guideline states that the arms should be covered during two activities only, in Recommendation I.c.1.' The perioperative team member should wear scrub attire that covers the arms while performing preoperative patient skin antisepsis.' And in Recommendation I.c.2: 'The perioperative or sterile processing team member should wear scrub attire that covers the arms while preparing and packaging items in the clean assembly section of the sterile processing area.' AORN has never stated in the surgical attire guideline that non-disposable head covering should be covered with a disposable head cover. The foremost concern for all perioperative professionals should be for patient safety and for providing the cleanest surgical environment possible for all patients undergoing operative and other invasive procedures. Within a bundled approach for reducing risk of SSIs, covering and containing hair is a reasonable and prudent measure. There is no harm in doing so, but the benefit to all patients is a reduced risk of exposure to potentially pathogenic organisms that live on the hair, skin, and facial hair of perioperative team members."

References:

AORN. Guideline for surgical attire. In: Guidelines for Perioperative Practice. 2017:105-127.

Elmously A, Gray KD, et al. Operating Room Attire Policy and Healthcare Cost: Favoring Evidence over Action for Prevention of Surgical Site Infections. (Presented at the Surgical Forum of the American College of Surgeons 104th Annual Clinical Congress, Scientific Forum, Boston, October 2018.) J American College of Surgeons. January 2019 Volume 228, Issue 1, Pages 98–106

Farach SM, Kelly KN, et al. Have Recent Modifications of Operating Room Attire Policies Decreased Surgical Site Infections? An American College of Surgeons NSQIP Review of 6,517 Patients. J Am Coll Surg. Vol. 226, No. 5. Pages 804-813. May 2018.

Kothari SN, Anderson MJ, et al. Bouffant vs Skull Cap and Impact on Surgical Site Infection: Does Operating Room Headwear Really Matter? Abstract presented at the American College of Surgeons 103rd Annual Clinical Congress, Scientific Forum, San Diego. October 2017. J Am Coll Surg. Vol. 227, No. 2. Pages 198-202. August 2018.