627
Participants
Start Date
February 18, 2015
Primary Completion Date
March 13, 2017
Study Completion Date
March 13, 2017
IrriSept System
"The IrriSept system consists of two containers: Step1, a sterile bottle of 450 mL 0.05% Chlorhexidine Gluconate in 99.95% water and Step 2, a sterile bottle of 450 mL of sterile 0.9% Normal Saline. Step 1 and Step 2 are identical in shape and size, with a clear distinction in labeling between. Their unique design allows the solutions to be delivered under the ideal pressure as determined by the surgeon via manual compression for wound and surgical irrigation.~Subjects randomized to the IrriSept system will receive irrigation per the provided Instructions for use; those randomized to Standard of Care will receive routine care per discretion of the investigator and in accordance with the institution's guidelines, which may or may not include some other type of irrigation."
No Intervention - Standard of Care (SoC) only
Institution will provide routine Standard of Care (SoC) as surgical preparation for subjects with abdominal trauma or acute surgical abdomen.
The University of Maryland, Baltimore, Baltimore
The University of South Florida, Tampa General Hospital, Tampa
Regional One Health Research Institute, Memphis
The University of Kentucky Research Foundation, Lexington
The University of Cincinnati Health, Cincinnati
The University of Iowa, Iowa City
The Medical College of Wisconsin, Milwaukee
Saint Louis University, St Louis
The MetroHealth System, Cleveland
The University of Texas Southwestern Medical Center, Dallas
The University of Texas Health Science Center at Houston, Houston
The University of Texas Health Science Center at San Antonio, San Antonio
Denver Health and Hospital Authority, Denver
The University of Arizona, Tucson
The University of Southern California, USC Medical Center, Los Angeles
The University of Washington, Harborview Medical Center, Seattle
Baystate Medical Center, Springfield
Lead Sponsor
Irrimax Corporation
INDUSTRY