Glove Perforation May Increase the Risk for Surgical Site Infection

Surgical glove perforation increases the risk for surgical site infection (SSI) unless antimicrobial prophylaxis is used, according to the results of a prospective observational cohort study reported in the June issue of the Archives of Surgery.

"All surgical staff members wear sterile gloves as a protective barrier to prevent hand-to-wound contamination during operations," write Heidi Misteli, MD, from University Hospital Basel in Basel, Switzerland, and colleagues. "When gloves are perforated, the barrier breaks down and germs are transferred. With the growing awareness among operating room staff of their risk of exposure to disease from patients, primarily human immunodeficiency virus and hepatitis B virus, gloves have begun to be regarded as a requirement for their own protection."

This study took place at University Hospital Basel, in which approximately 28,000 surgical procedures are performed each year. For this analysis, the study sample was a consecutive series of 4147 surgical procedures performed in the Visceral Surgery, Vascular Surgery, and Traumatology divisions of the Department of General Surgery. The main endpoint of the study was rate of SSI, as defined by the Centers for Disease Control and Prevention (CDC), and the main predictor variable was compromised asepsis because of glove perforation.

Of 4147 procedures performed, 188 (4.5%) overall were associated with SSI. Compared with procedures in which asepsis was maintained, procedures in which gloves were perforated had a higher likelihood of SSI, based on univariate logistic regression analysis (odds ratio [OR], 2.0; 95% confidence interval [CI], 1.4 - 2.8; P < .001).

The increase in the risk for SSI with glove perforation was different when surgical antimicrobial prophylaxis was or was not used (multivariate logistic regression analyses test for effect modification, P = .005). When antimicrobial prophylaxis was not used, the odds of SSI were significantly higher for glove perforation vs the group in which asepsis was maintained (adjusted OR, 4.2; 95% CI, 1.7 - 10.8; P = .003). In contrast, the likelihood of SSI was not significantly higher for procedures in which gloves were punctured when surgical antimicrobial prophylaxis was used (adjusted OR, 1.3; 95% CI, 0.9 - 1.9; P = .26).

"Without surgical antimicrobial prophylaxis, glove perforation increases the risk of SSI," the study authors write. "To our knowledge, this is the first study to explore the correlation between SSI and glove leakage in a large series of surgical procedures."

Limitations of this study include 22.1% missing data on glove perforation, prospective observational vs randomized controlled design, possible residual or unknown confounding, and use of nonvalidated techniques to detect glove leakage. Since this study was performed from 2000 to 2001, there have been significant changes in circulating relevant bacteria.

"Efforts to decrease the frequency of glove perforation, such as double gloving and the routine changing of gloves during lengthy surgical procedures, are therefore encouraged," the study authors conclude. "The present results support an extended indication of surgical antimicrobial prophylaxis to all clean procedures in the absence of strict precautions taken to prevent glove perforation. The advantages of this SSI prevention strategy, however, must be balanced against the costs and adverse effects of the prophylactic antimicrobials, such as drug reactions or increased bacterial resistance."

In an accompanying invited critique, Edward E. Cornwell III, MD, from Howard University Hospital in Washington, DC, notes additional study limitations.

"I do not believe the recommendation to extend antibiotic prophylaxis guidelines is justified," Dr. Cornwell writes. "Although the risk of SSI (with vs without glove perforation) among patients without antibiotic prophylaxis was significant on multivariate analysis, the data in this and other studies cited by the authors much more strongly support the measures suggested for lowering the risk of glove perforation. These measures would be substantially cheaper, more promising for efficacy, and less likely to produce allergies or adverse effects than giving prophylactic antibiotics to all patients."

The Department of General Surgery, University Hospital Basel, and the Freiwillige Akademische Gesellschaft Basel funded this study. The study authors and Dr. Cornwell have disclosed no relevant financial relationships.

Arch Surg. 2009;144:553-558.

Clinical Context

Despite the precautions deployed to maintain asepsis during surgery, the risk for transfer of pathogens remains. The transfer of skin-borne pathogens from staff hands is especially prevalent. All surgical staff members wear sterile gloves as a protective barrier to prevent hand-to-wound contamination during operations. However, the barrier breaks down as soon as the gloves are perforated. Factors leading to an increased risk for perforation include duration of operating time (significantly after 2 hours); improperly fit gloves; and puncture by needles, spiked bone fragments, or sharp surfaces on complex instruments. The impact of glove perforation on the risk for SSI is unknown.

The aim of this study was to determine whether clinically apparent surgical glove perforation increases the risk for SSI.

Study Highlights

• From January 1, 2000, through December 31, 2001, a prospective observational cohort study was performed at the University Hospital Basel to evaluate the incidence of SSI in association with surgical glove perforation.
• Consecutive series of 4147 surgical procedures performed in the Visceral Surgery, Vascular Surgery, and Traumatology divisions of the Department of General Surgery were enrolled.
• Operations requiring no incision and procedures classified as wound class 4 (dirty infected) according to the CDC criteria were excluded from the study.
• The outcome of interest was SSI occurrence as assessed according to the CDC standards.
• All incidents of SSI were validated by a board-certified infectious disease specialist on the basis of a comprehensive review of the patient history, initial microbiology results, and outcome at least 30 days after surgery when no implants were involved or more than 1 year after surgery if an implant was in place.
• The primary predictor variable was compromised asepsis because of glove perforation.
• Prophylactic antimicrobial administration was given according to the CDC guidelines. Patients received antimicrobial prophylaxis if they underwent surgery classified as CDC wound classes 3 (contaminated), 2 (clean contaminated), and 1 (clean) involving a nonabsorbable implant or at the discretion of the surgeon.
• Results of the study demonstrated that the overall SSI rate was 4.5% (188/4147 procedures).
• SSI was classified as the following: superficial (n = 56), deep (n = 62), and organ/space (n = 70).
• Asepsis was compromised by glove leakage in 677 interventions (16.3%); 51 instances (7.5%) of SSI were recorded from the compromised asepsis. In comparison, there were 137 instances in 3470 procedures (3.9%) when asepsis was not breached.
• Univariate logistic regression analysis showed a higher likelihood of SSI in procedures in which gloves were perforated vs interventions with maintained asepsis (OR, 2.0; 95% CI, 1.4 - 2.8; P < .001).
• However, multivariate logistic regression analyses showed that the increase in SSI risk with perforated gloves was different for procedures with surgical antimicrobial prophylaxis vs those without surgical antimicrobial prophylaxis (test for effect modification, P = .005).
• Data were further analyzed for the risk association separately for glove perforations in surgeries with and without antimicrobial prophylaxis.
• Without antimicrobial prophylaxis, glove perforation entailed significantly higher odds of SSI vs the reference group with no breach of asepsis (adjusted OR, 4.2; 95% CI, 1.7 - 10.8; P = .003).
• On the contrary, when surgical antimicrobial prophylaxis was applied, the likelihood of SSI was not significantly higher for operations in which gloves were punctured (adjusted OR, 1.3; 95% CI, 0.9 - 1.9; P = .26).
• Limitations of this study were that 22.1% of the information on glove perforation was missing, the study was a prospective observational study vs a randomized controlled trial, nonvalidated techniques were used to detect glove leakage, and results may be inapplicable because of changes in circulating relevant bacteria since this study was conducted from 2000 to 2001.

Clinical Implications

• Factors that may lead to glove perforation include puncture by needles, spiked bone fragments, or sharp surfaces on complex instruments as well as duration of operating time (> 2 hours) and gloves that do not fit properly.
• In the absence of surgical antimicrobial prophylaxis, glove perforation increased the risk for SSI.

Source : http://cme.medscape.com/viewarticle/704548?sssdmh=dm1.487338&src=nldne