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

Surgical Site Infection Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02255487
• Other study ID #: IRR-CT-901-2013-01
• Status: Terminated
• Phase: N/A
• Start date: February 18, 2015
• Est. completion date: March 13, 2017

Study information

• Verified date: April 2022
• Source: Irrimax Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 627
• Est. completion date: March 13, 2017
• Est. primary completion date: March 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Surgical Site Infection
• Surgical Wound Infection

Intervention

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.

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.

Locations

Country	Name	City	State
United States	The University of Maryland, Baltimore	Baltimore	Maryland
United States	The University of Cincinnati Health	Cincinnati	Ohio
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 Texas Health Science Center at Houston	Houston	Texas
United States	The University of Iowa	Iowa City	Iowa
United States	The University of Kentucky Research Foundation	Lexington	Kentucky
United States	The University of Southern California, USC Medical Center	Los Angeles	California
United States	Regional One Health Research Institute	Memphis	Tennessee
United States	The Medical College of Wisconsin	Milwaukee	Wisconsin
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 University of Washington, Harborview Medical Center	Seattle	Washington
United States	Baystate Medical Center	Springfield	Massachusetts
United States	The University of South Florida, Tampa General Hospital	Tampa	Florida
United States	The University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Irrimax Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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