Use of an intraoperative wound protector to prevent surgical-site infection after pancreatoduodenectomy: randomized clinical trial

Background Surgical-site infection (SSI) increases treatment costs, duration of hospital stay and readmission rate after pancreatic surgery. This study aimed to assess whether a wound protector could reduce the risk of superficial incisional SSI after pancreatoduodenectomy. Methods This RCT included patients undergoing pancreatoduodenectomy at Verona University Hospital, between 2017 and 2018. The experimental group had a dual-ring wound protector, whereas the control group had standard surgical drapes. The groups were stratified by preoperative biliary stent placement. The primary outcome was the overall rate of superficial SSI. Results An interim analysis was conducted after 212 patients had been enrolled; 22 patients (10 center dot 4 per cent) were excluded owing to inability to complete the pancreatoduodenectomy, or the need for postoperative reintervention. Some 94 patients (49 center dot 5 per cent) had a wound protector and 96 (50 center dot 5 per cent) had standard drapes. There were no differences between groups in demographics, or in intraoperative findings, pathological data or surgical outcomes. The overall superficial SSI rate was 7 center dot 4 per cent, which did not differ between groups (7 per cent in each group;P = 0 center dot 585). Subanalysis of patients with a preoperative biliary stent showed a similar outcome (superficial SSI rate 9versus8 per cent with wound protectorversussurgical drapes respectively;P = 0 center dot 536). The trial was stopped prematurely on the grounds of futility. Conclusion Use of a wound protector did not reduce the rate of superficial SSI after pancreatoduodenectomy. Registration number: NCT03820648 ().