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

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).

The clinical effectiveness of wound edge protectors in reducing surgical site infection after abdominal surgery: meta-analysis

“…2 ). Six included trials were considered as high quality 15 , 17 , 19 , 23 , 38 , 40 , 13 were considered moderate quality 12 , 16 , 18 , 20–22 , 24–28 , 31 , 41 , and 2 were considered low quality 29 , 30 , 39 ( Fig. 2 ).…”

“…Previous studies revealed that dual-loop devices are more effective in reducing SSI incidence; however, there are limited available data on dual-ring devices, and so, sufficient robust high-quality testing is warranted 33 , 34 . This article includes newly published RCTs of high quality that employed dual-ring devices 38 , 40 , 41 . It has been suggested that double-ring devices might prevent SSI more effectively than single-ring devices 37 .…”

Effect of wound protectors on surgical site infection in patients undergoing whipple procedure

“…3 To date, there are two randomized controlled clinical trials evaluating the effect of wound protectors on SSI in patients undergoing PD that have published conflicting results. 3,7,8 In one randomized controlled trial from Canada, wound protectors significantly decreased the incidence of superficial or deep SSI with a relative risk reduction of 52% in patients undergoing elective PD who had preoperative biliary stents. 3 In the other randomized controlled trial from Italy, wound protectors did not reduce the risk of superficial SSI following PD in patients with or without preoperative biliary stent placement.…”

“…3 In the other randomized controlled trial from Italy, wound protectors did not reduce the risk of superficial SSI following PD in patients with or without preoperative biliary stent placement. 8 Peri-operative bundles to reduce superficial or deep SSI following PD have been examined. 2,9 Such studies have included the use of wound protectors in such bundles, in addition to other practices such as gown/glove/drape change prior to closure of fascia, wound irrigation, negative pressure incisional wound dressing placement, midline incision, and use of peri-operative broad spectrum antibiotics.…”

“…2,9,10 While all of these practices may be beneficial in preventing SSI following PD, there remains conflicting information regarding the utility of wound protectors in particular, for SSI prevention in patients undergoing PD. 3,7,8 Therefore, the primary aim of this study is to examine the effect of wound protectors on superficial or deep SSI risk in a large sample of propensity-score matched patients undergoing elective PD. Secondary outcomes include a stratified analysis by presence of preoperative biliary stent, other infectious complications, as well as 30-day morbidity and mortality.…”