Status:
TERMINATED
Irrisept Versus Standard of Care in the Prevention of Surgical Site Infections
Lead Sponsor:
Irrimax Corporation
Conditions:
Surgical Site Infection
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
The trial was explained to potential subjects, the informed consent was completed and and eligibility was verified. After this, the subjects were randomized to Irrisept or SoC and an open abdominal la...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 18 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2017
Estimated Enrollment :
627 Patients enrolled
Trial Details
Trial ID
NCT02255487
Start Date
February 18 2015
End Date
March 13 2017
Last Update
May 24 2022
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
The University of Arizona
Tucson, Arizona, United States, 85724
2
The University of Southern California, USC Medical Center
Los Angeles, California, United States, 90033
3
Denver Health and Hospital Authority
Denver, Colorado, United States, 80204
4
The University of South Florida, Tampa General Hospital
Tampa, Florida, United States, 33606