Efficacy of a dual-ring wound protector for prevention of incisional surgical site infection after Whipple's procedure (pancreaticoduodenectomy) with preoperatively-placed intrabiliary stents: protocol for a randomised controlled trial

Abstract

IntroductionAmong surgical oncology patients, incisional surgical site infection is associated with substantially increased morbidity, mortality and healthcare costs. Moreover, while adults undergoing pancreaticoduodenectomy with preoperative placement of an intrabiliary stent have a high risk of this type of infection, and wound protectors may significantly reduce its risk, no relevant studies of wound protectors yet exist involving this patient population. This study will evaluate the efficacy of a dual-ring wound protector for prevention of incisional surgical site infection among adults undergoing pancreaticoduodenectomy with preoperatively-placed intrabiliary stents.Methods and analysisThis study will be a parallel, dual-arm, randomised controlled trial that will utilise a more explanatory than pragmatic attitude. All adults (≥18 years) undergoing a pancreaticoduodenectomy at the Foothills Medical Centre in Calgary, Alberta, Canada with preoperative placement of an intrabiliary stent will be considered eligible. Exclusion criteria will include patient age <18 years and those receiving long-term glucocorticoids. The trial will employ block randomisation to allocate patients to a commercial dual-ring wound protector (the Alexis Wound Protector) or no wound protector and the current standard of care. The main outcome measure will be the rate of surgical site infection as defined by the Centers for Disease Control and Prevention criteria within 30 days of the index operation date as determined by a research assistant blinded to treatment allocation. Outcomes will be analysed by a statistician blinded to allocation status by calculating risk ratios and 95% CIs and compared using Fisher's exact test.Ethics and disseminationThis will be the first randomised trial to evaluate the efficacy of a dual-ring wound protector for prevention of incisional surgical site infection among patients undergoing pancreaticoduodenectomy. Results of this study are expected to be available in 2016/2017 and will be disseminated using an integrated and end-of-grant knowledge translation strategy.Trial registration numberClinicalTrials.gov identifier NCT01836237.

Determinants of Surgical Site Infections Following Pancreatoduodenectomy

“…Post-operative pancreatic anastomotic leak/fistula (POPF), delayed gastric emptying (DGE), bile leak and postpancreatectomy haemorrhage (PPH) were defined as per the International Study Group of Pancreatic Surgery (ISGPS) criteria [20][21][22]. Mortality was defined as any death that has occurred not only in the 30 days following surgery but even thereafter so long as there exists sufficient evidence to link the cause of death to the surgery or its complications.…”

Disparities in the management and prophylaxis of surgical site infection and pancreatic fistula after pancreatoduodenectomy

“…A recent meta‐analysis including 1,008 patients demonstrated that wound protector reduced the rates of SSIs after gastrointestinal and biliary surgery . A randomized controlled trial evaluating the efficacy of wound protector in PD is currently underway and results are forthcoming . The lack of level I recommendations may explain the low number of surgeons currently using wound protector (30%).…”

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

“…Given randomized controlled clinical trial data suggesting the use of wound protectors in patients with preoperative biliary stents to be protective against surgical site infection, we planned an additional stratified analysis by use of preoperative biliary stents, either internal endoscopic stents or external percutaneous stents. 3,7 Outcome of interest The primary outcome of interest was defined as either superficial or deep SSI within 30 days. Superficial SSIs are characterized by postoperative cellulitis, typically involving only the skin or subcutaneous tissues for which antibiotic therapy is administered.…”

“…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.…”

“…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.…”