Applied Medical’s Alexis wound protector/retractor has significantly reduced pancreaticoduodenectomy (PD) surgical site infection (SSI) in a clinical study.
Alexis wound protector/retractor decreased incisional SSI in PD procedures by 52% compared against cases that did not use a wound protector, said Applied Medical.
Alexis wound protector/retractor has been clinically validated to reduce incisional SSI across multiple surgical specialties, in addition to reducing incisional SSI in PD procedures.
The multicenter, parallel, dual-arm, double-blind, randomized controlled trial has been designed to asses the efficacy of the Alexis wound protector/retractor to reduce the risk of incisional SSI among patients with a biliary stent undergoing an elective PD.
The trial compared the use of the dual-ring wound protector to the current standard of care at the Foothills Medical Centre and The Ottawa Hospital in Calgary and Ottawa, Canada.
Alexis wound protector/retractor group is included with 57 patients, while the no-wound-protector group is included with 50 patients.
The data safety panel halted the trial at the first planned interim analysis, after finding that the risk of incisional SSI was significantly lower with the use of dual-ring wound protectors.
Featuring a dual-ring design, the Alexis wound protector/retractor is available in a wide range of sizes for use within multiple specialties.
The protector/retractor provides 360-degree protection to help reduce surgical site infection, shield incision sites from bacterial invasion and maintain moisture to promote healing.
Applied Medical is a new generation medical device company engaged in the development of advanced solutions for use in minimally invasive surgery.
According to the company, SSI accounts for 20% of healthcare-associated infections, resulting in around $3.5bn to $10bn annual healthcare expenditures in the US.
Applied Medical horizon II division president Serene Wachli said: “It’s our company’s mission to make a meaningful, positive difference by enhancing surgical outcomes.
“We’re proud to design, develop and manufacture our Alexis wound protectors, which have been shown to be effective in helping reduce SSI in a wide variety of procedures.”