Retrospective Independent Safety Review of Closed Irrisept Study

NCT05359666 | Completed Results DMC FDA Device

• 1 other identifier: CLP-01
• Study Type: interventional
• Target: 592
• Locations: 1 country
• Sites: 17

Brief Summary

The purpose of CLP-01 was to complete the safety endpoint of the closed trial and ensure that all safety data generated by IRR-CT-901-2013-01 was accounted for and accurately identified, verified, and independently adjudicated. CLP-01 does not include an evaluation of the efficacy or exploratory endpoints from IRR-CT-901-2013-01. CLP-01 did not enroll new subjects and relied solely on data collected in the subject source and medical records in IRR-CT-901-2013-01. CLP-01 was conducted between March 2020 and November 2021.

Conditions

Adverse Events

Outcome Measures

Primary Outcomes (1)

• All Adverse Events

  The primary endpoint was identification of all adverse events from subjects that participated in the closed study (Protocol #IRR-CT-901-2013-01; NCT #02255487).

  up to 30 +/- 3 days

Secondary Outcomes (3)

• Subjects With Device-Related Adverse Events

  up to 30 +/- 3 days

• Number of Device-Related Adverse Events

  up to 30 +/- 3 days

• Number of Device Deficiencies

  up to 30 +/- 3 days

Study Arms (2)

Irrisept

EXPERIMENTAL

Irrisept® was used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen for study protocol IRR-CT-901-2013-01.

Device: Irrisept

Standard of Care (SoC)

ACTIVE COMPARATOR

Institution determined the type of SoC used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen for study protocol IRR-CT-901-2013-01.

Device: Standard of Care

Interventions

Irrisept DEVICE

Irrisept® is a manual, self-contained irrigation device designed for wound cleansing and irrigation. The solution is 0.05% Chlorhexidine Gluconate (CHG) in sterile water for irrigation, USP (99.95%). Irrisept contents include the solution, a 450 mL bottle, and the Irriprobe applicator. Irrisept is a manual, self-contained irrigation device that can produce 7-8 psi of pressure for effective wound cleansing and irrigation. The user squeezes the bottle to create streams of solution and directs the fluid from the applicator onto a wound. The mechanical action of the streams of fluid being applied over a wound removes particulates and debris. Subjects randomized to Irrisept on study protocol IRR-CT-901-2013-01 used the device, per the provided Instructions for Use. Those randomized to SoC received routine care, per the discretion of the investigator, and in accordance with the institution's guidelines.

Irrisept

Standard of Care DEVICE

Subjects randomized to SoC on study protocol IRR-CT-901-2013-01 used any SoC type, per the investigator's discretion. SoC types were not standardized. Sites recorded SoC information as free text. The following were recorded as SoC types: Saline (recorded as "normal", "warm" and/or "sterile" saline or saline solution); Sodium Chloride (recorded as "sodium chloride (NACL)" or "NACL 0.9%"); "SoC"; Irrisept (recorded as "normal saline \& Irrisept" and "Irrisept"); Chloraprep; "Gentamicin \& saline"; unknown; and none.

Standard of Care (SoC)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously consented subjects from the closed study
• Subjects randomized to use Irrisept or SoC in the closed study
• Subjects who had a procedure in the hospital
• Subjects who used irrigation during the hospital procedure
• Subjects who had data that could be monitored and verified

You may not qualify if:

• The total number of subjects in this population - the mITT population - was 592.

Sponsors & Collaborators

• Irrimax Corporation: lead

Study Sites (17)

University of Arizona Department of Surgery

Tucson, Arizona, 85724, United States

Location

Los Angeles County & USC Medical Center

Los Angeles, California, 90033, United States

Location

Denver Health Medical Center

Denver, Colorado, 80203, United States

Location

Tampa General Hospital University of South Florida (USF) College of Medicine

Tampa, Florida, 33606, United States

Location

University of Iowa Department of Surgery - 1504 JCP

Iowa City, Iowa, 52242, United States

Location

University of Kentucky Department of Surgery

Lexington, Kentucky, 40536, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Baystate Medical Center Surgery Research, S3613

Springfield, Massachusetts, 01199, United States

Location

St. Louis University Department of Surgery

St Louis, Missouri, 63110, United States

Location

University of Cincinnati Division of Trauma/Critical Care Department of Surgery

Cincinnati, Ohio, 45267, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

University of Tennessee Health Science Center

Memphis, Tennessee, 38103, United States

Location

University of Texas Southwestern (UTSW) Medical Center

Dallas, Texas, 75390, United States

Location

University of Texas Health Science Center (UTHSC) at Houston Center for Translational Injury Research

Houston, Texas, 77030, United States

Location

The University of Texas Health Center at San Antonio Division of Trauma and Emergency Surgery

San Antonio, Texas, 78229, United States

Location

University of Washington Harborview Medical Center Department of Surgery

Seattle, Washington, 98104, United States

Location

Medical College of Wisconsin Division of Trauma & Acute Care Surgery

Milwaukee, Wisconsin, 53226, United States

Location

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Irrimax Corporation

cs@irrisept.com

770-807-3355

Study Officials

• Chevy J Brown, MPH

  Director, Clinical Trials

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The randomization methodology was controlled by the site for the IRR-CT-901-2013-01 trial. There was no additional randomization for CLP-01.

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: May 4, 2022
• Study Start: March 31, 2020
• Primary Completion: November 29, 2021
• Study Completion: November 29, 2021
• Last Updated: August 14, 2023
• Results First Posted: August 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)