Clinical trial NCT05359666: Retrospective Independent Safety Review of Closed Irrisept Study
Official title: An Independent Review of Safety Data From a Closed Clinical Study Using Irrisept (Protocol IRR-CT-901-2013-01)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Events
Lead sponsor: Irrimax Corporation
Sponsor class: INDUSTRY
First posted: 2022-05-04
Enrollment: 592
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The randomization methodology was controlled by the site for the IRR-CT-901-2013-01 trial. There was no additional randomization for CLP-01.
Primary purpose: OTHER

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: All Adverse Events
timeFrame: up to 30 +/- 3 days
Secondary outcomes:
measure: Subjects With Device-Related Adverse Events
timeFrame: up to 30 +/- 3 days
measure: Number of Device-Related Adverse Events
timeFrame: up to 30 +/- 3 days
measure: Number of Device Deficiencies
timeFrame: up to 30 +/- 3 days
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Department of Surgery
state: Arizona
city: Los Angeles
country: United States
facility: Los Angeles County & USC Medical Center
state: California
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
city: Tampa
country: United States
facility: Tampa General Hospital University of South Florida (USF) College of Medicine
state: Florida
city: Iowa City
country: United States
facility: University of Iowa Department of Surgery - 1504 JCP
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky Department of Surgery
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Springfield
country: United States
facility: Baystate Medical Center Surgery Research, S3613
state: Massachusetts
city: Saint Louis
country: United States
facility: St. Louis University Department of Surgery
state: Missouri
city: Cincinnati
country: United States
facility: University of Cincinnati Division of Trauma/Critical Care Department of Surgery
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern (UTSW) Medical Center
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center (UTHSC) at Houston Center for Translational Injury Research
state: Texas
city: San Antonio
country: United States
facility: The University of Texas Health Center at San Antonio Division of Trauma and Emergency Surgery
state: Texas
city: Seattle
country: United States
facility: University of Washington Harborview Medical Center Department of Surgery
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Division of Trauma & Acute Care Surgery
state: Wisconsin
Study officials:
affiliation: Director, Clinical Trials
name: Chevy J Brown, MPH
role: STUDY_DIRECTOR
References: