Use of an intraoperative wound protector to prevent surgical-site infection after pancreatoduodenectomy: randomized clinical trial. Issue 9 (12th March 2020)

• Record Type: Journal Article
• Authors: De Pastena, M; Marchegiani, G; Paiella, S; Fontana, M; Esposito, A; Casetti, L; Secchettin, E; Manzini, G; Bassi, C; Salvia, R
• Is Part Of: British journal of surgery. Volume 107:Issue 9(2020)
• Page Start: 1107
• Page End: 1113
• Publication Date: 2020-03-12
• Subjects: Surgery -- Periodicals; 617.005
• DOI: 10.1002/bjs.11527
• Languages: English
• ISSNs: 0007-1323

Abstract

Abstract: 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 (10·4 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. Conclusion: Use of a wound protector did not reduce the rate of superficial SSI after pancreatoduodenectomy. Registration number: NCT03820648 (http://www.clinicaltrials.gov ). Graphical Abstract: This RCT assessed whether a wound protector could reduce the risk of superficial incisional surgical-site infection (SSI) in patients undergoing pancreatoduodenectomy. In a high-volume centre, use of a wound protector alone did not reduce the superficial SSI rate. It could be introduced in a wider implementation programme, which should be directed at local issues in the reduction of infectious complications. Likely ineffective