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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 627
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • The University of Arizona
  • California
    • Los Angeles, California, United States, 90033
      • The University of Southern California, USC Medical Center
  • Colorado
    • Denver, Colorado, United States, 80204
      • Denver Health and Hospital Authority
  • Florida
    • Tampa, Florida, United States, 33606
      • The University of South Florida, Tampa General Hospital
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • The University of Iowa
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • The University of Kentucky research foundation
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • The University of Maryland, Baltimore
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Saint Louis University
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • The University of Cincinnati Health
    • Cleveland, Ohio, United States, 73160
      • The MetroHealth System
  • Tennessee
    • Memphis, Tennessee, United States, 38163
      • Regional One Health Research Institute
  • Texas
    • Dallas, Texas, United States, 75390
      • The University of Texas Southwestern Medical Center
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
    • San Antonio, Texas, United States, 78229
      • The University of Texas Health Science Center at San Antonio
  • Washington
    • Seattle, Washington, United States, 98104
      • The University of Washington, Harborview Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • The Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IrriSept System; IrriSept device used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen	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.
Active Comparator: Standard of Care (SoC) only; Institution will provide routine Standard of Care (SoC) surgical preparation for subjects with abdominal trauma or acute surgical abdomen.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Readmission Rates	A secondary endpoint was the rate of Irrisept versus SoC subjects that required hospital readmission due to SSIs.	30 (+/- 3) days post-surgical procedure
Hospital Costs	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.	0 days
Length of Hospital Stay	A secondary endpoint was the length of hospital stay between subjects randomized to Irrisept versus SoC.	30 (+/- 3) days post-surgical procedure

Collaborators and Investigators

• Sponsor: Irrimax Corporation
• Investigators: Study Director: Donald Fry, MD, Michael Pine Associates

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2015
• Primary Completion (Actual): March 13, 2017
• Study Completion (Actual): March 13, 2017

Study Registration Dates

• First Submitted: September 30, 2014
• First Submitted That Met QC Criteria: October 1, 2014
• First Posted (Estimate): October 2, 2014

Study Record Updates

• Last Update Posted (Actual): May 24, 2022
• Last Update Submitted That Met QC Criteria: April 29, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Wound Infection; Infections; Communicable Diseases; Surgical Wound Infection
• Other Study ID Numbers: IRR-CT-901-2013-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes