Study Stopped
The study was terminated early after the Interim Analysis due, in part, to issues with the accuracy and completeness of the data collected.
Irrisept Versus Standard of Care in the Prevention of Surgical Site Infections
A Phase IV, Multicenter, Prospective, Randomized, Controlled Clinical Study to Compare the Irrisept System Versus Standard of Care (SoC) on the Prevalence of Surgical Site Infections in Patients With Abdominal Trauma or Acute Surgical Abdomen
1 other identifier
interventional
627
1 country
17
Brief Summary
The purpose of this study was to compare the rate of surgical site infections in patients randomized to Irrisept versus SoC, who had an open abdominal laparotomy for abdominal trauma or acute surgical abdomen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2015
Typical duration for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2014
CompletedFirst Posted
Study publicly available on registry
October 2, 2014
CompletedStudy Start
First participant enrolled
February 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 13, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 13, 2017
CompletedResults Posted
Study results publicly available
May 24, 2022
CompletedMay 24, 2022
April 1, 2022
2.1 years
September 30, 2014
October 18, 2021
April 29, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Percent of Subjects With Surgical Site Infections (SSI)
The primary endpoint was the rate of SSIs observed 30 days from the date of the index operation.
30 (+/- 3) days post-surgical procedure
Secondary Outcomes (3)
Hospital Readmission Rates
30 (+/- 3) days post-surgical procedure
Hospital Costs
0 days
Length of Hospital Stay
30 (+/- 3) days post-surgical procedure
Study Arms (2)
IrriSept System
EXPERIMENTALIrriSept device used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen
Standard of Care (SoC) only
ACTIVE COMPARATORInstitution will provide routine Standard of Care (SoC) surgical preparation for subjects with abdominal trauma or acute surgical abdomen.
Interventions
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.
Institution will provide routine Standard of Care (SoC) as surgical preparation for subjects with abdominal trauma or acute surgical abdomen.
Eligibility Criteria
You may qualify if:
- Is male or female, 18 years of age or older
- Has provided written informed consent or has surrogate consent provided by a Legally Authorized Representative (LAR)
- Has experienced abdominal trauma, blunt or penetrating, requiring open abdominal laparotomy with primary closure or
- Has experienced acute surgical abdomen requiring open abdominal laparotomy with primary closure
You may not qualify if:
- Known allergy to Chlorhexidine Gluconate (CHG)
- Estimated Abbreviated Injury Scale (AIS) score of six (6) at the time of surgery, for all trauma patients
- American Society of Anesthesiologists Physical Status Classification (ASA) score of five (5) or greater (As ASA scoring is a subjective measure, if the PI finds the patient stable enough for study participation despite a score of 5, enrollment may continue.)
- Female volunteers who are pregnant and/or breast feeding
- Damage control laparotomy
- Abdominal incision created prior to operating room (i.e. incision made in trauma bay to cross clamp the aorta)
- Currently enrolled in an ongoing, interventional, randomized clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
The University of Arizona
Tucson, Arizona, 85724, United States
The University of Southern California, USC Medical Center
Los Angeles, California, 90033, United States
Denver Health and Hospital Authority
Denver, Colorado, 80204, United States
The University of South Florida, Tampa General Hospital
Tampa, Florida, 33606, United States
The University of Iowa
Iowa City, Iowa, 52242, United States
The University of Kentucky Research Foundation
Lexington, Kentucky, 40536, United States
The University of Maryland, Baltimore
Baltimore, Maryland, 21201, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Saint Louis University
St Louis, Missouri, 63110, United States
The University of Cincinnati Health
Cincinnati, Ohio, 45267, United States
The MetroHealth System
Cleveland, Ohio, 73160, United States
Regional One Health Research Institute
Memphis, Tennessee, 38163, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
The University of Washington, Harborview Medical Center
Seattle, Washington, 98104, United States
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chevy Brown, Clinical Trials Manager
- Organization
- Irrimax Corporation
Study Officials
- STUDY DIRECTOR
Donald Fry, MD
Michael Pine Associates
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2014
First Posted
October 2, 2014
Study Start
February 18, 2015
Primary Completion
March 13, 2017
Study Completion
March 13, 2017
Last Updated
May 24, 2022
Results First Posted
May 24, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share