SAN DIEGO (FRONTLINE MEDICAL NEWS) – Implementation of strict operating room (OR) attire policies did not reduce the rates of superficial surgical site infections (SSIs), according to an analysis of more than 6,500 patients.

“SSIs are the most common cause of health care–associated infections in the U.S.,” study author Sandra Farach, MD, said at the annual clinical congress of the American College of Surgeons. “It’s estimated that SSIs occur in 2%-5% of patients undergoing inpatient surgery. They’re associated with significant patient morbidity and mortality and are a significant burden to the health care system, accounting for an estimated $3.5 to $10 billion in health care expenditures.”

In February 2015, the Association for periOperative Registered Nurses published recommendations on operating room attire, providing a guideline for modifying facility policies and regulatory requirements. It included stringent policies designed to minimize the exposed areas of skin and hair of operating room staff. “New attire policies were met with some criticism as there is a paucity of evidence-based data to support these recommendations,” said Dr. Farach, who helped conduct the study during her tenure as chief resident of general surgery at the University of Rochester (N.Y.) Medical Center.

Following a department of health site visit, two tertiary care teaching hospitals imposed strict regulations on operating attire. This included covering of the head, hair, eyes, and all facial hair, as well as banning the use of skull caps. Dr. Farach and her associates hypothesized that this intervention would reduce incisional SSIs. They also sought to determine whether more stringent regulation of these policies would result in a greater decrease in SSIs by comparing SSI rates at the two institutions. The researchers queried the institutional American College of Surgeons National Surgical Quality Improvement Program database for all patients undergoing surgery in the 9 months before implementation of the new OR policies (from September 2014 to May 2015) and compared it with time-matched data from 9 months after implementation (from September 2015 to May 2016) at the two hospitals. They used univariate and multivariable analyses to examine patient, clinical, and operative factors associated with incisional SSI. Secondary endpoints included length of stay, mortality, and major/minor complications.

A total of 6,517 patients were included in the analysis: 3,077 in the preimplementation group and 3,440 patients in the postimplementation group. The postimplementation group tended to be older and had significantly higher rates of hypertension, dialysis treatments, steroid use, and systemic inflammatory response syndrome, as well as higher American Society of Anesthesiologists classification scores. “However, they had a significantly lower BMI, incidence of smoking and COPD, and a higher incidence of clean wounds, which would theoretically leave them less exposed to SSIs,” said Dr. Farach, who is now a pediatric surgical critical care fellow at Le Bonheur Children’s Hospital in Memphis.

Overall, the rate of SSIs by wound class increased between the preimplementation and postimplementation time periods: The percent of change was 0.6%, 0.9%, 2.3%, and 3.8% in the clean, clean-contaminated, contaminated, and dirty/infected cases, respectively. When the review was limited to clean or clean-contaminated cases, SSI increased slightly, from 0.7% to 0.8% (P = .085). There were no significant differences in the complication rate, 30-day mortality, unplanned return to the OR, or length of stay between preimplementation or postimplementation at either hospital.

When Dr. Farach and her associates examined the overall infection rate, they observed no significant differences preimplementation and postimplementation in the rates of incisional SSI (0.97% vs. 0.96%, respectively; P = .949), organ space SSI (1.20% vs. 0.81%; P = .115), and total SSIs (2.11% vs. 1.77%; P = .321). Multivariate analysis showed that implementation of OR changes was not associated with an increased risk of SSIs. Factors that did predict high SSI rates included preoperative SSI (adjusted odds ratio 23.04), long operative time (AOR 3.4), preoperative open wound (AOR 2.94), contaminated/dirty wound classes (AOR 2.32), and morbid obesity (AOR 1.8).

“A hypothetical analysis revealed that a sample of over 495,000 patients would be required to demonstrate a 10% incisional SSI reduction among patients with clean or clean-contaminated wounds,” Dr. Farach noted. “Nevertheless, the study showed a numerical increase in SSI during the study period. Policies regarding OR attire were universally unpopular. As a result, OR governance is now working to repeal these new policies at both hospitals.”

“Given the rarity of SSI in the population subset which is relevant to the OR attire question (clean and clean-contaminated wounds, 0.7%), designing a study to prove effectiveness of an intervention (i.e., a 10% improvement) is totally impractical to conduct as this would require nearly a half a million cases,” said Jacob Moalem, MD , the lead author of the study who is an endocrine surgeon at the University of Rochester. At the meeting, a discussant suggested that conducting such a study is feasible; however, “I would strongly argue that putting that many people through such a study, when we know that these attire rules have a deleterious effect on surgeon comfort and OR team dynamics and morale, would not be prudent,” Dr. Moalem said. “We know that surgeon comfort, ability to focus on the task at hand, and minimizing distractions in the OR are critically important in reducing errors. In my opinion, by continuing to focus on these unfounded attire restrictions, one would be far more likely to actually cause injury to a patient than to prevent a wound infection.”

The researchers reported having no financial disclosures.


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