Retrospective Independent Safety Review of Closed Irrisept Study

An Independent Review of Safety Data From a Closed Clinical Study Using Irrisept (Protocol IRR-CT-901-2013-01)

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.

Study Overview

• Status: Completed
• Conditions: Adverse Events
• Intervention / Treatment: Device: Irrisept; Device: Standard of Care

Detailed Description

Between 2013 and 2016, Irrimax Corporation sponsored a prospective clinical study (IRR-CT-901-2013-01; NCT02255487) in the United States under IRB approval. IRR-CT-901-2013-01 defined primary and secondary efficacy, exploratory, and safety endpoints. The safety endpoint from IRR-CT-901-2013-01 was a clinical review and analysis of Adverse Events (AEs). However, IRR-CT-901-2013-01 was terminated early after the Interim Analysis primarily because of issues with the accuracy and completeness of the data collected for IRR-CT-901-2013-01, the lack of SoC standardization, and challenges assessing study endpoints arising out of the complexity of the trauma and co-morbidities of the subjects enrolled. The sole purpose of CLP-01 was to complete the safety endpoint for IRR-CT-901-2013-01.

CLP-01 reviewed all AEs recorded in IRR-CT-901-2013-01 and identified additional AEs in the subject source and medical records. All AEs were assessed for severity and causality and were reviewed by the individual Principal Investigators (PIs) at each site and the CLP-01 Medical Monitor (MM).

• Study Type: Interventional
• Enrollment (Actual): 592
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona Department of Surgery
  • California
    • Los Angeles, California, United States, 90033
      • Los Angeles County & USC Medical Center
  • Colorado
    • Denver, Colorado, United States, 80203
      • Denver Health Medical Center
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital University of South Florida (USF) College of Medicine
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Department of Surgery - 1504 JCP
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Department of Surgery
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center Surgery Research, S3613
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • St. Louis University Department of Surgery
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati Division of Trauma/Critical Care Department of Surgery
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • University of Tennessee Health Science Center
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern (UTSW) Medical Center
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center (UTHSC) at Houston Center for Translational Injury Research
    • San Antonio, Texas, United States, 78229
      • The University of Texas Health Center at San Antonio Division of Trauma and Emergency Surgery
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington Harborview Medical Center Department of Surgery
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin Division of Trauma & Acute Care Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

-Subjects who did not meet all inclusion criteria

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

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; 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; 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.
Active Comparator: Standard of Care (SoC); 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects With Device-Related Adverse Events	The secondary endpoint was identification of the number subjects with device-related adverse events from those that participated in the closed study (Protocol #IRR-CT-901-2013-01; NCT #02255487).	up to 30 +/- 3 days
Number of Device-Related Adverse Events	Another secondary endpoint was identification of the overall number device-related adverse events from subjects that participated in the closed study (Protocol #IRR-CT-901-2013-01; NCT #02255487).	up to 30 +/- 3 days
Number of Device Deficiencies	For the Irrisept group only, any device deficiencies identified in the medical records and/or source documents (during the closed study when the study device was used, even if the deficiency was not associated with an AE), was recorded.	up to 30 +/- 3 days

Collaborators and Investigators

• Sponsor: Irrimax Corporation
• Investigators: Study Director: Chevy J Brown, MPH, Director, Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2020
• Primary Completion (Actual): November 29, 2021
• Study Completion (Actual): November 29, 2021

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CLP-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.: No