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

Primary Purpose

Surgical Site Infection

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IrriSept System
No Intervention - Standard of Care (SoC) only
Sponsored by
Irrimax Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Surgical Site Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Arizona
  • The University of Southern California, USC Medical Center
  • Denver Health and Hospital Authority
  • The University of South Florida, Tampa General Hospital
  • The University of Iowa
  • The University of Kentucky Research Foundation
  • The University of Maryland, Baltimore
  • Baystate Medical Center
  • Saint Louis University
  • The University of Cincinnati Health
  • The MetroHealth System
  • Regional One Health Research Institute
  • The University of Texas Southwestern Medical Center
  • The University of Texas Health Science Center at Houston
  • The University of Texas Health Science Center at San Antonio
  • The University of Washington, Harborview Medical Center
  • The Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IrriSept System

Standard of Care (SoC) only

Arm Description

IrriSept device used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen

Institution will provide routine Standard of Care (SoC) surgical preparation for subjects with abdominal trauma or acute surgical abdomen.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Hospital Readmission Rates
A secondary endpoint was the rate of Irrisept versus SoC subjects that required hospital readmission due to SSIs.
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.
Length of Hospital Stay
A secondary endpoint was the length of hospital stay between subjects randomized to Irrisept versus SoC.

Full Information

First Posted
September 30, 2014
Last Updated
April 29, 2022
Sponsor
Irrimax Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02255487
Brief Title
Irrisept Versus Standard of Care in the Prevention of Surgical Site Infections
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated early after the Interim Analysis due, in part, to issues with the accuracy and completeness of the data collected.
Study Start Date
February 18, 2015 (Actual)
Primary Completion Date
March 13, 2017 (Actual)
Study Completion Date
March 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Irrimax Corporation

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The randomization methodology was controlled by the site.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
627 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IrriSept System
Arm Type
Experimental
Arm Description
IrriSept device used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen
Arm Title
Standard of Care (SoC) only
Arm Type
Active Comparator
Arm Description
Institution will provide routine Standard of Care (SoC) surgical preparation for subjects with abdominal trauma or acute surgical abdomen.
Intervention Type
Device
Intervention Name(s)
IrriSept System
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No Intervention - Standard of Care (SoC) only
Intervention Description
Institution will provide routine Standard of Care (SoC) as surgical preparation for subjects with abdominal trauma or acute surgical abdomen.
Primary Outcome Measure Information:
Title
Percent of Subjects With Surgical Site Infections (SSI)
Description
The primary endpoint was the rate of SSIs observed 30 days from the date of the index operation.
Time Frame
30 (+/- 3) days post-surgical procedure
Secondary Outcome Measure Information:
Title
Hospital Readmission Rates
Description
A secondary endpoint was the rate of Irrisept versus SoC subjects that required hospital readmission due to SSIs.
Time Frame
30 (+/- 3) days post-surgical procedure
Title
Hospital Costs
Description
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.
Time Frame
0 days
Title
Length of Hospital Stay
Description
A secondary endpoint was the length of hospital stay between subjects randomized to Irrisept versus SoC.
Time Frame
30 (+/- 3) days post-surgical procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Fry, MD
Organizational Affiliation
Michael Pine Associates
Official's Role
Study Director
Facility Information:
Facility Name
The University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
The University of Southern California, USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Denver Health and Hospital Authority
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
The University of South Florida, Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
The University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
The University of Kentucky Research Foundation
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
The University of Maryland, Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
The University of Cincinnati Health
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
The MetroHealth System
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
73160
Country
United States
Facility Name
Regional One Health Research Institute
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
The University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
The University of Washington, Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
The Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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