Clinical Trial: IrrSept vs. Standard of Care in Prevention of Surgical Site Infections

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional




Official Title: A Phase IV, Multicenter, Prospective, Randomized, Controlled Clinical Study to Compare the IrriSept System Versus Standard of Care on the Prevalence of Surgical Site Infection in Patients With Abdomin

Brief Summary: This is a Phase IV study designed to evaluate rate of Surgical Site Infections (SSIs) when the IrriSept device is used in an open abdominal laparotomy for abdominal trauma or acute surgical abdomen. Half of the eligible subjects will be randomized to receive the IrriSept device and half of the subjects will receive the respective institution's Standard of Care (SoC).