Harry T Papaconstantinou1, Rocco Ricciardi2,3, David A Margolin4, Roberto Bergamaschi5, Robert C Moesinger6, Warren E Lichliter7, Elisa H Birnbaum8. 1. Department of Surgery, Baylor Scott & White Healthcare, Texas A&M University College of Medicine, 2401 South 31st Street, Temple, TX, USA. Harry.Papaconstantinou@bswhealth.org. 2. Massachusetts General Hospital, Boston, MA, USA. 3. Department of Surgery, Lahey Hospital and Medical Center, 41 Burlington Mall Road, Burlington, MA, USA. 4. Department of Colon and Rectal Surgery, University of Queensland, Ochsner Clinical School, 1514 Jefferson Highway, New Orleans, LA, USA. 5. Division of Colon and Rectal Surgery, State University at Stony Brook, 101 Nicolls Road, Stony Brook, NY, USA. 6. Northern Utah Surgeons, Intermountain Healthcare, University of Utah, 4401 Harrison Blvd, Ste 1635, Ogden, UT, USA. 7. Baylor University Medical Center, 3500 Gaston Avenue, 1 Roberts, Dallas, TX, USA. 8. Department of Surgery, Section of Colon and Rectal Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8109, St. Louis, MO, USA.
Abstract
BACKGROUND: Surgical site infection (SSI) remains a persistent and morbid problem in colorectal surgery. Key to its pathogenesis is the degree of intraoperative bacterial contamination at the surgical site. The purpose of this study was to evaluate a novel wound retractor at reducing bacterial contamination. METHODS: A prospective multicenter pilot study utilizing a novel wound retractor combining continuous irrigation and barrier protection was conducted in patients undergoing elective colorectal resections. Culture swabs were collected from the incision edge prior to device placement and from the exposed and protected incision edge prior to device removal. The primary and secondary endpoints were the rate of enteric and overall bacterial contamination on the exposed incision edge as compared to the protected incision edge, respectively. The safety endpoint was the absence of serious device-related adverse events. RESULTS: A total of 86 patients were eligible for analysis. The novel wound retractor was associated with a 66% reduction in overall bacterial contamination at the protected incision edge compared to the exposed incision edge (11.9 vs. 34.5%, P < 0.001), and 71% reduction in enteric bacterial contamination (9.5% vs. 33.3%, P < 0.001). The incisional SSI rate was 2.3% in the primary analysis and 1.2% in those that completed the protocol. There were no adverse events attributed to device use. CONCLUSIONS: A novel wound retractor combining continuous irrigation and barrier protection was associated with a significant reduction in bacterial contamination. Improved methods to counteract wound contamination represent a promising strategy for SSI prevention (NCT 02413879).
BACKGROUND: Surgical site infection (SSI) remains a persistent and morbid problem in colorectal surgery. Key to its pathogenesis is the degree of intraoperative bacterial contamination at the surgical site. The purpose of this study was to evaluate a novel wound retractor at reducing bacterial contamination. METHODS: A prospective multicenter pilot study utilizing a novel wound retractor combining continuous irrigation and barrier protection was conducted in patients undergoing elective colorectal resections. Culture swabs were collected from the incision edge prior to device placement and from the exposed and protected incision edge prior to device removal. The primary and secondary endpoints were the rate of enteric and overall bacterial contamination on the exposed incision edge as compared to the protected incision edge, respectively. The safety endpoint was the absence of serious device-related adverse events. RESULTS: A total of 86 patients were eligible for analysis. The novel wound retractor was associated with a 66% reduction in overall bacterial contamination at the protected incision edge compared to the exposed incision edge (11.9 vs. 34.5%, P < 0.001), and 71% reduction in enteric bacterial contamination (9.5% vs. 33.3%, P < 0.001). The incisional SSI rate was 2.3% in the primary analysis and 1.2% in those that completed the protocol. There were no adverse events attributed to device use. CONCLUSIONS: A novel wound retractor combining continuous irrigation and barrier protection was associated with a significant reduction in bacterial contamination. Improved methods to counteract wound contamination represent a promising strategy for SSI prevention (NCT 02413879).
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