Irrisept Versus Standard of Care in the Prevention of Surgical Site Infections

NATerminatedINTERVENTIONAL
Enrollment

627

Participants

Timeline

Start Date

February 18, 2015

Primary Completion Date

March 13, 2017

Study Completion Date

March 13, 2017

Conditions
Surgical Site Infection
Interventions
DEVICE

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."

OTHER

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.

Trial Locations (17)

21201

The University of Maryland, Baltimore, Baltimore

33606

The University of South Florida, Tampa General Hospital, Tampa

38163

Regional One Health Research Institute, Memphis

40536

The University of Kentucky Research Foundation, Lexington

45267

The University of Cincinnati Health, Cincinnati

52242

The University of Iowa, Iowa City

53226

The Medical College of Wisconsin, Milwaukee

63110

Saint Louis University, St Louis

73160

The MetroHealth System, Cleveland

75390

The University of Texas Southwestern Medical Center, Dallas

77030

The University of Texas Health Science Center at Houston, Houston

78229

The University of Texas Health Science Center at San Antonio, San Antonio

80204

Denver Health and Hospital Authority, Denver

85724

The University of Arizona, Tucson

90033

The University of Southern California, USC Medical Center, Los Angeles

98104

The University of Washington, Harborview Medical Center, Seattle

01199

Baystate Medical Center, Springfield

Sponsors
All Listed Sponsors
lead

Irrimax Corporation

INDUSTRY