Retrospective Independent Safety Review of Closed Irrisept Study
- Conditions
- Adverse Events
- Interventions
- Device: Standard of CareDevice: Irrisept
- Registration Number
- NCT05359666
- Lead Sponsor
- Irrimax Corporation
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 592
- 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
-Subjects who did not meet all inclusion criteria
The total number of subjects in this population - the mITT population - was 592.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care (SoC) Standard of Care 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. Irrisept Irrisept Irrisept® was used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen for study protocol IRR-CT-901-2013-01.
- Primary Outcome Measures
Name Time Method All Adverse Events up to 30 +/- 3 days 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).
- Secondary Outcome Measures
Name Time Method Subjects With Device-Related Adverse Events up to 30 +/- 3 days 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).
Number of Device Deficiencies up to 30 +/- 3 days 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.
Number of Device-Related Adverse Events up to 30 +/- 3 days 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).
Trial Locations
- Locations (17)
Los Angeles County & USC Medical Center
🇺🇸Los Angeles, California, United States
University of Arizona Department of Surgery
🇺🇸Tucson, Arizona, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Baystate Medical Center Surgery Research, S3613
🇺🇸Springfield, Massachusetts, United States
University of Tennessee Health Science Center
🇺🇸Memphis, Tennessee, United States
University of Iowa Department of Surgery - 1504 JCP
🇺🇸Iowa City, Iowa, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, 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 Cincinnati Division of Trauma/Critical Care Department of Surgery
🇺🇸Cincinnati, Ohio, United States
The University of Texas Health Center at San Antonio Division of Trauma and Emergency Surgery
🇺🇸San Antonio, Texas, United States
Medical College of Wisconsin Division of Trauma & Acute Care Surgery
🇺🇸Milwaukee, Wisconsin, United States
University of Kentucky Department of Surgery
🇺🇸Lexington, Kentucky, United States
St. Louis University Department of Surgery
🇺🇸Saint Louis, Missouri, 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
University of Washington Harborview Medical Center Department of Surgery
🇺🇸Seattle, Washington, United States