Adverse EventsNCT05359666
Retrospective Independent Safety Review of Closed Irrisept Study
A study testing Irrisept in people with Adverse Events, run by Irrimax Corporation at 17 sites in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adverse Events
- What is being tested?
- Irrisept
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 592 participants
- Where
- 17 sitesUnited States
- Study dates
- 31 Mar 2020to 29 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -Subjects who did not meet all inclusion criteria
- The total number of subjects in this population - the mITT population - was 592.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
University of Maryland
Baltimore, Maryland, 21201
University of Cincinnati Division of Trauma/Critical Care Department of Surgery
Cincinnati, Ohio, 45267
MetroHealth Medical Center
Cleveland, Ohio, 44109
University of Texas Southwestern (UTSW) Medical Center
Dallas, Texas, 75390
Denver Health Medical Center
Denver, Colorado, 80203
University of Texas Health Science Center (UTHSC) at Houston Center for Translational Injury Research
Houston, Texas, 77030
University of Iowa Department of Surgery - 1504 JCP
Iowa City, Iowa, 52242
University of Kentucky Department of Surgery
Lexington, Kentucky, 40536
Los Angeles County & USC Medical Center
Los Angeles, California, 90033
University of Tennessee Health Science Center
Memphis, Tennessee, 38103
Medical College of Wisconsin Division of Trauma & Acute Care Surgery
Milwaukee, Wisconsin, 53226
The University of Texas Health Center at San Antonio Division of Trauma and Emergency Surgery
San Antonio, Texas, 78229
University of Washington Harborview Medical Center Department of Surgery
Seattle, Washington, 98104
Baystate Medical Center Surgery Research, S3613
Springfield, Massachusetts, 01199
St. Louis University Department of Surgery
St Louis, Missouri, 63110
Tampa General Hospital University of South Florida (USF) College of Medicine
Tampa, Florida, 33606
University of Arizona Department of Surgery
Tucson, Arizona, 85724
About this study
Official title: An Independent Review of Safety Data From a Closed Clinical Study Using Irrisept (Protocol IRR-CT-901-2013-01)
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.
Read the 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).
- Conditions
- Adverse Events
- Being tested
- Irrisept, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrriseptDevice
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 CareDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Irrisept | Experimental | Irrisept® was used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen for study protocol IRR-CT-901-2013-01. Receives: Device: Irrisept |
| Standard of Care (SoC) | Active comparator | 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. Receives: Device: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 30 +/- 3 days
Secondary outcomes (3)
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).
Measured: up to 30 +/- 3 days
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).
Measured: up to 30 +/- 3 days
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.
Measured: up to 30 +/- 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start31 Mar 2020
- Primary completion29 Nov 2021
- Study completion29 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adverse EventsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 592 participants (actual)
Sponsor and investigators
- Lead sponsor
- Irrimax Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chevy J Brown, MPH, Study director, Director, Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359666
- Sponsor's protocol ID
- CLP-01
- Status last verified
- Jul 2023
- First submitted
- 18 Apr 2022
- Last updated
- 14 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Independent Review of Safety Data From a Closed Clinical Study Using Irrisept (Protocol IRR-CT-901-2013-01)
- ClinicalTrials.gov ID
- NCT05359666
- Acronym / sponsor ID
- CLP-01
- Conditions
- Adverse Events
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 592 participants (actual)
- Lead sponsor
- Irrimax CorporationIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2020 (actual)
- Primary completion
- 29 Nov 2021 (actual)
- Study completion
- 29 Nov 2021 (actual)
- First posted
- 4 May 2022 (actual)
- Results
- Posted 14 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Irrisept | Experimental | Device: IrriseptIrrisept® was used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen for study protocol IRR-CT-901-2013-01. |
| Standard of Care (SoC) | Active comparator | Device: Standard of CareInstitution 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- -Subjects who did not meet all inclusion criteria
- The total number of subjects in this population - the mITT population - was 592.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IrriseptIrrisept® 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. | Device | Irrisept |
| Standard of CareSubjects 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. | Device | Standard of Care (SoC) |
Primary outcome
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).
3 secondary outcomes
Subjects With Device-Related Adverse Events
Time frame: up to 30 +/- 3 days
Number of Device-Related Adverse Events
Time frame: up to 30 +/- 3 days
Number of Device Deficiencies
Time frame: up to 30 +/- 3 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chevy J Brown, MPH study director
Director, Clinical Trials
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irrisept in people with Adverse Events, run by Irrimax Corporation at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All Adverse Events (time frame: up to 30 +/- 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.