Objective: To evaluate whether intraoperative subcutaneous wound irrigation with 0.04% polyhexanide can reduce surgical site infection (SSI) in elective laparotomies compared to saline. Background: SSI 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. Methods: The 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. Results: Between 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. Conclusions: Intraoperative subcutaneous wound irrigation with antiseptic 0.04% polyhexanide solution is effective in reducing SSI after elective laparotomies.

Purpose Surgical site infection (SSI) occurs in up to 25% of patients after elective laparotomy. We aimed to determine the effect of SSI on healthcare costs and patients’ quality of life. Methods In this post hoc analysis based on the RECIPE trial, we studied a 30-day postoperative outcome of SSI in a single-center, prospective randomized controlled trial comparing subcutaneous wound irrigation with 0.04% polyhexanide to 0.9% saline after elective laparotomy. Total medical costs were analyzed accurately per patient with the tool of our corporate controlling team which is based on diagnosis-related groups in Germany. Results Between November 2015 and May 2018, 456 patients were recruited. The overall rate of SSI was 28.2%. Overall costs of inpatient treatment were higher in the group with SSI: median 16.685 €; 19.703 USD (IQR 21.638 €; 25.552 USD) vs. median 11.235 €; 13.276 USD (IQR 11.564 €; 13.656 USD); p < 0.001. There was a difference in surgery costs (median 6.664 €; 7.870 USD with SSI vs. median 5.040 €; 5.952 USD without SSI; p = 0.001) and costs on the surgical ward (median 8.404 €; 9.924 USD with SSI vs. median 4.690 €; 5.538 USD without SSI; p < 0.001). Patients with SSI were less satisfied with the cosmetic result (4.3% vs. 16.2%; p < 0.001). Overall costs for patients who were irrigated with saline were median 12.056 €; 14.237 USD vs. median 12.793 €; 15.107 USD in the polyhexanide group (p = 0.52). Conclusion SSI after elective laparotomy increased hospital costs substantially. This is an additional reason why the prevention of SSI is important. Overall costs for intraoperative wound irrigation with saline were comparable with polyhexanide.

Background: An anastomotic leak (AL) after a restorative proctocolectomy and an ileal J-pouch increases morbidity and the risk of pouch failure. Thus, a perfusion assessment during J-pouch formation is crucial. While indocyanine green near-infrared fluorescence (ICG-NIRF) has shown potential to reduce ALs, its suitability in a restorative proctocolectomy remains unclear. We aimed to develop a standardized approach for investigating ICG-NIRF and ALs in pouch surgery. Methods: Patients undergoing a restorative proctocolectomy with an ileal J-pouch for ulcerative colitis at an IBD-referral-center were included in a prospective study in which an AL within 30 postoperative days was the primary outcome. Intraoperatively, standardized perfusion visualization with ICG-NIRF was performed and video recorded for postoperative analysis at three time points. Quantitative clinical and technical variables (secondary outcome) were correlated with the primary outcome by descriptive analysis and logistic regression. A novel definition and grading of AL of the J-pouch was applied. A postoperative pouchoscopy was routinely performed to screen for AL. Results: Intraoperative ICG-NIRF-visualization and its postoperative visual analysis in 25 patients did not indicate an AL. The anastomotic site after pouch formation appeared completely fluorescent with a strong fluorescence signal (category 2) in all cases of ALs (4 of 25). Anastomotic site was not changed. ICG-NIRF visualization was reproducible and standardized. Logistic regression identified a two-stage approach vs. a three-stage approach (Odds ratio (OR) = 20.00, 95% confidence interval [CI] = 1.37–580.18, p = 0.029) as a risk factor for ALs. Conclusion: We present a standardized, comparable approach of ICG-NIRF visualization in pouch surgery. Our data indicate that the visual interpretation of ICG-NIRF alone may not detect ALs of the pouch in all cases—quantifiable, objective methods of interpretation may be required in the future.