• M De Pastena, G Marchegiani, S Paiella, M Fontana, A Esposito, L Casetti, E Secchettin, G Manzini, C Bassi, and R Salvia.
• Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.
• Br J Surg. 2020 Aug 1; 107 (9): 1107-1113.

BackgroundSurgical-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.MethodsThis 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.ResultsAn interim analysis was conducted after 212 patients had been enrolled; 22 patients (10·4 per cent) were excluded owing to inability to complete the pancreatoduodenectomy, or the need for postoperative reintervention. Some 94 patients (49·5 per cent) had a wound protector and 96 (50·5 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 7·4 per cent, which did not differ between groups (7 per cent in each group; P = 0·585). Subanalysis of patients with a preoperative biliary stent showed a similar outcome (superficial SSI rate 9 versus 8 per cent with wound protector versus surgical drapes respectively; P = 0·536). The trial was stopped prematurely on the grounds of futility.ConclusionUse of a wound protector did not reduce the rate of superficial SSI after pancreatoduodenectomy. Registration number: NCT03820648 (http://www.clinicaltrials.gov).© 2020 BJS Society Ltd Published by John Wiley & Sons Ltd.

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