Retrospective Independent Safety Review of Closed Irrisept Study

Completed · Not applicable

Conditions studied: Adverse Events

In brief

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.

Key facts

Study ID

NCT05359666

Run by

Irrimax Corporation

People needed

592

Starts

2020-03-31

Expected to finish

2021-11-29

Last updated by the study team

2023-08-14

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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…

• Subjects who did not meet all inclusion criteria
• The total number of subjects in this population - the mITT population - was 592.

Where it is running

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

Full record on ClinicalTrials.gov

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