As we hypothesise superiority of the dual-ring wound protector over the current standard of care, we plan to examine for evidence of this in statistical hypothesis tests.
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.
Moreover, among patients treated with dual-ring versus single-ring wound protectors, the pooled estimated risk of SSI was 0.31 (95% CI 0.14 to 0.67) times the pooled estimated risk in the control groups.
This will be the first RCT to assess whether a dual-ring wound protector is efficacious in reducing the risk of incisional SSI among adults undergoing Whipple's procedure preceded by preoperative placement of intrabiliary stents.
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.
In order to maintain allocation concealment, the assigned intervention (ie, dual-ring wound protector or standard of care) will be provided to the surgeon in an opaque, sealed envelope immediately before surgery by the research assistant.
First randomised clinical trial to assess efficacy of a dual-ring wound protector in reducing the risk of incisional surgical site infection (SSI) after Whipple's procedure with preoperative placement of an intrabiliary stent.
Patients previously fitted with an intrabiliary drainage stent will be randomly assigned in the preoperative period to treatment with a commercial dual-ring wound protector (The Alexis Wound Protector (Applied Medical, Rancho Santa Margarita, California, USA)) or no wound protector and the current standard of care during the conduct of a pancreaticoduodenectomy (Whipple's procedure).
Thus, the objective of this study is to evaluate the efficacy of a dual-ring wound protector versus no wound protector and the current standard of care for reducing the risk of 30-day incisional SSI among patients undergoing pancreaticoduodenectomy with preoperatively-placed intrabiliary stents.
This 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.
Gunshots rang out, wounding at least eight demonstrators and prompting the panicked crowd to flee, according to activists and videos shot at the event.
