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

Not Applicable

Terminated

• Conditions: Surgical Site Infection
• Interventions: Device: IrriSept System; Other: No Intervention - Standard of Care (SoC) only

• Registration Number: NCT02255487
• Lead Sponsor: Irrimax Corporation

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.

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 laparotomy with primary closure due to (1) blunt or penetrating abdominal trauma or (2) acute surgical abdomen was performed. The follow-up visit was performed approximately 30 days later.

Study Timeline

• Study First Submitted: 2014-09-30
• Study First Submitted QC: 2014-10-01
• Study First Posted: 2014-10-02
• Study Start: 2015-02-18
• Primary Completion: 2017-03-13
• Study Completion: 2017-03-13
• Results First Submitted: 2021-10-18
• Status Verified: 2022-04
• Results First Submitted QC: 2022-04-29
• Last Update Submitted: 2022-04-29
• Results First Posted: 2022-05-24
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 627

Inclusion Criteria

1. Is male or female, 18 years of age or older
2. Has provided written informed consent or has surrogate consent provided by a Legally Authorized Representative (LAR)
3. Has experienced abdominal trauma, blunt or penetrating, requiring open abdominal laparotomy with primary closure or
4. Has experienced acute surgical abdomen requiring open abdominal laparotomy with primary closure

Exclusion Criteria

1. Known allergy to Chlorhexidine Gluconate (CHG)
2. Estimated Abbreviated Injury Scale (AIS) score of six (6) at the time of surgery, for all trauma patients
3. 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.)
4. Female volunteers who are pregnant and/or breast feeding
5. Damage control laparotomy
6. Abdominal incision created prior to operating room (i.e. incision made in trauma bay to cross clamp the aorta)
7. Currently enrolled in an ongoing, interventional, randomized clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IrriSept System	IrriSept System	IrriSept device used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen
Standard of Care (SoC) only	No Intervention - Standard of Care (SoC) only	Institution will provide routine Standard of Care (SoC) surgical preparation for subjects with abdominal trauma or acute surgical abdomen.

Primary Outcome Measures

Name	Time	Method
Percent of Subjects With Surgical Site Infections (SSI)	30 (+/- 3) days post-surgical procedure	The primary endpoint was the rate of SSIs observed 30 days from the date of the index operation.

Secondary Outcome Measures

Name	Time	Method
Hospital Costs	0 days	A secondary endpoint was the estimated hospital cost to charge ratio between Irrisept and SoC subjects. No data was collected towards this objective; thus, the success or failure of this endpoint was not assessed.
Hospital Readmission Rates	30 (+/- 3) days post-surgical procedure	A secondary endpoint was the rate of Irrisept versus SoC subjects that required hospital readmission due to SSIs.
Length of Hospital Stay	30 (+/- 3) days post-surgical procedure	A secondary endpoint was the length of hospital stay between subjects randomized to Irrisept versus SoC.

Trial Locations

Locations (17)

The University of Cincinnati Health; 🇺🇸 Cincinnati, Ohio, United States

The University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Saint Louis University; 🇺🇸 Saint Louis, Missouri, United States

The University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States

The Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

The University of Southern California, USC Medical Center; 🇺🇸 Los Angeles, California, United States

The University of Maryland, Baltimore; 🇺🇸 Baltimore, Maryland, United States

The MetroHealth System; 🇺🇸 Cleveland, Ohio, United States

The University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, 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 Kentucky Research Foundation; 🇺🇸 Lexington, Kentucky, United States

The University of Washington, Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States

The University of Arizona; 🇺🇸 Tucson, Arizona, United States

Baystate Medical Center; 🇺🇸 Springfield, Massachusetts, United States

Regional One Health Research Institute; 🇺🇸 Memphis, Tennessee, United States