-
Randomized Controlled Trial
Reduction of Postoperative Wound Infections by Antiseptica (RECIPE)?: A Randomized Controlled Trial.
- Rahel M Strobel, Marja Leonhardt, Anika Krochmann, Konrad Neumann, Fiona Speichinger, Lisa Hartmann, Lucas D Lee, Katharina Beyer, Severin Daum, Martin E Kreis, and Johannes C Lauscher.
- Department of General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin, Hindenburgdamm, Berlin, Germany.
- Ann. Surg. 2020 Jul 1; 272 (1): 55-64.
ObjectiveTo evaluate whether intraoperative subcutaneous wound irrigation with 0.04% polyhexanide can reduce surgical site infection (SSI) in elective laparotomies compared to saline.BackgroundSSI is a common complication after gastrointestinal surgery. To date, there is a lack of evidence whether subcutaneous wound irrigation is beneficial in terms of reduction of SSI.MethodsThe RECIPE trial was an investigator initiated single-center, single-blind prospective, randomized controlled trial with 2 parallel treatment groups, comparing wound irrigation with 0.9% saline to antiseptic 0.04% polyhexanide solution in elective laparotomies. Primary endpoint was the rate of SSI within 30 days postoperatively according to Centers for Disease Control and Prevention criteria.ResultsBetween February 02, 2015, and May 23, 2018, 456 patients were randomly assigned to saline (n = 228) or polyhexanide (n = 228). Final cohort for analysis comprised 393 patients (202 in the saline and 191 in the polyhexanide group). Overall rate of SSI was 28.2%, n = 111. Simple analysis with cross tabulation revealed that significantly fewer SSIs occurred in the polyhexanide group: n = 70 (34.7%) versus n = 41 (21.5%); P = 0.004. In a multiple logistic regression model the factor wound irrigation with polyhexanide [odds ratio (OR) 0.44; 95% confidence interval (CI) 0.27-0.72; P = 0.001) was associated with risk reduction of SSI. Preoperative anemia (OR 2.08; 95% CI 1.27-3.40; P = 0.004) and more than 5 prior abdominal operations compared to none (OR 8.51; 95% CI 2.57-28.21; P < 0.001) were associated with SSI.ConclusionsIntraoperative subcutaneous wound irrigation with antiseptic 0.04% polyhexanide solution is effective in reducing SSI after elective laparotomies.
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