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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05359666
Other study ID # CLP-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 31, 2020
Est. completion date November 29, 2021

Study information

Verified date July 2023
Source Irrimax Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 592
Est. completion date November 29, 2021
Est. primary completion date November 29, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States University of Maryland Baltimore Maryland
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 Texas Southwestern (UTSW) Medical Center Dallas Texas
United States Denver Health Medical Center Denver Colorado
United States University of Texas Health Science Center (UTHSC) at Houston Center for Translational Injury Research Houston Texas
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 Los Angeles County & USC Medical Center Los Angeles California
United States University of Tennessee Health Science Center Memphis Tennessee
United States Medical College of Wisconsin Division of Trauma & Acute Care Surgery Milwaukee Wisconsin
United States St. Louis University Department of Surgery Saint Louis Missouri
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 Baystate Medical Center Surgery Research, S3613 Springfield Massachusetts
United States Tampa General Hospital University of South Florida (USF) College of Medicine Tampa Florida
United States University of Arizona Department of Surgery Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
Irrimax Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
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