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

Stopped early · Not applicable

Conditions studied: Surgical Site Infection

In brief

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.

Key facts

Study ID

NCT02255487

Run by

Irrimax Corporation

People needed

627

Starts

2015-02-18

Expected to finish

2017-03-13

Last updated by the study team

2022-05-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• The University of Arizona — Tucson, Arizona, United States
• The University of Southern California, USC Medical Center — Los Angeles, California, United States
• Denver Health and Hospital Authority — Denver, Colorado, United States
• The University of South Florida, Tampa General Hospital — Tampa, Florida, United States
• The University of Iowa — Iowa City, Iowa, United States
• The University of Kentucky Research Foundation — Lexington, Kentucky, United States
• The University of Maryland, Baltimore — Baltimore, Maryland, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• Saint Louis University — St Louis, Missouri, United States
• The University of Cincinnati Health — Cincinnati, Ohio, United States
• The MetroHealth System — Cleveland, Ohio, United States
• Regional One Health Research Institute — Memphis, Tennessee, United States
• The University of Texas Southwestern Medical Center — Dallas, Texas, United States
• The University of Texas Health Science Center at Houston — Houston, Texas, United States
• The University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
• The University of Washington, Harborview Medical Center — Seattle, Washington, United States
• The Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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