Skip to main content
OpenTrials
Completed

NCT Number: NCT05359666

Retrospective Independent Safety Review of Closed Irrisept Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adverse Events

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona Department of Surgery, Tucson, Arizona, United States

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Irrisept

Device

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

Device

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.

Primary outcomes

  1. All Adverse Events

    Time frame: 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 outcomes

  1. Subjects With Device-Related Adverse Events

    Time frame: 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).

  2. Number of Device-Related Adverse Events

    Time frame: 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).

  3. Number of Device Deficiencies

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Irrimax Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 4, 2022
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.