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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of Device-Related Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
-Subjects who did not meet all inclusion criteria
The total number of subjects in this population - the mITT population - was 592.
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| Name | Affiliation | Role |
|---|---|---|
| Chevy J Brown, MPH | Director, Clinical Trials | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Department of Surgery | Tucson | Arizona | 85724 | United States | ||
| Los Angeles County & USC Medical Center |
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CLP-01 included safety data only from trial IRR-CT-901-2013-01. There were 636 ITT subjects (i.e., those who consented into IRR-CT-901-2013-01). There were 592 mITT subjects (i.e., those who consented, randomized to Irrisept or SoC, had a procedure, used irrigation during that procedure & had verifiable safety data. Of the 592 mITT subjects, 294 subjects were given Irrisept & 298 subjects were given SOC. The remaining 44 subjects had non-evaluable data & were not included in the analysis.
CLP-01, a retrospective review study conducted between 03/2020 & 11/2021, did not enroll new subjects, but relied solely on data collected for the trial IRR-CT-901-2013-01.CLP-01's purpose was to complete the safety endpoint of the closed trial & ensure that all safety data generated by IRR-CT-901-2013-01 was accounted for & accurately identified, verified, & independently adjudicated. CLP-01 did not include an evaluation of the efficacy or exploratory endpoints from IRR-CT-901-2013-01.
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| ID | Title | Description |
|---|---|---|
| FG000 | Irrisept | For subjects randomized to the investigational group, Irrisept was used during the surgical procedure, per the provided instructions for use. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 9, 2019 | Apr 14, 2022 |
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The randomization methodology was controlled by the site for the IRR-CT-901-2013-01 trial. There was no additional randomization for CLP-01.
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| 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. |
|
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 |
| 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 |
| Los Angeles |
| California |
| 90033 |
| United States |
| Denver Health Medical Center | Denver | Colorado | 80203 | United States |
| Tampa General Hospital University of South Florida (USF) College of Medicine | Tampa | Florida | 33606 | United States |
| University of Iowa Department of Surgery - 1504 JCP | Iowa City | Iowa | 52242 | United States |
| University of Kentucky Department of Surgery | Lexington | Kentucky | 40536 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Baystate Medical Center Surgery Research, S3613 | Springfield | Massachusetts | 01199 | United States |
| St. Louis University Department of Surgery | St Louis | Missouri | 63110 | United States |
| University of Cincinnati Division of Trauma/Critical Care Department of Surgery | Cincinnati | Ohio | 45267 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| University of Tennessee Health Science Center | Memphis | Tennessee | 38103 | United States |
| University of Texas Southwestern (UTSW) Medical Center | Dallas | Texas | 75390 | United States |
| University of Texas Health Science Center (UTHSC) at Houston Center for Translational Injury Research | Houston | Texas | 77030 | United States |
| The University of Texas Health Center at San Antonio Division of Trauma and Emergency Surgery | San Antonio | Texas | 78229 | United States |
| University of Washington Harborview Medical Center Department of Surgery | Seattle | Washington | 98104 | United States |
| Medical College of Wisconsin Division of Trauma & Acute Care Surgery | Milwaukee | Wisconsin | 53226 | United States |
| FG001 | Standard of Care (SoC) | For subjects randomized to the control group, any SoC irrigation solution, preferred by the investigator, was used during the surgical procedure. SoC types were not standardized in IRR-CT-901-2013-01. 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"); Chloroprep; "Gentamicin & saline"; unknown; and none. |
| COMPLETED |
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| NOT COMPLETED |
|
Although age, gender, race and/or region data was collected on the prior trial IRR-CT-901-2013-01, this information was not verified during CLP-01, as this was not the intent of the trial. The purpose of CLP-01 was to ensure safety data was accounted for and accurately identified, verified, and independently adjudicated. CLP-01 did not include an evaluation of the efficacy or exploratory endpoints from IRR-CT-901-2013-01.
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| ID | Title | Description |
|---|---|---|
| BG000 | Irrisept | For subjects randomized to the investigational group, Irrisept was used during the surgical procedure, per the provided instructions for use. Baseline data for age, gender, race and region was not the purpose of CLP-01 and therefore was not collected for Irrisept subjects. The purpose of CLP-01 was to identify and assess adverse event causality and severity only. |
| BG001 | Standard of Care (SoC) | For subjects randomized to the control group, any SoC irrigation solution, preferred by the investigator, was used during the surgical procedure. Baseline data for age, gender, race and region was not the purpose of CLP-01 and therefore was not collected for SoC subjects. The purpose of CLP-01 was to identify and assess adverse event causality and severity only. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | |||||||||||||||||||||
| Sex: Female, Male |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | ||||||||||||||||||||
| Region of Enrollment | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Number | Adverse Events | up to 30 +/- 3 days |
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| 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). | Posted | Number | Subjects with Device-related AEs | 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). | Of the total 1856 adverse events, 894 occurred in subjects on Irrisept and 962 occurred in subjects on SoC. There were 1808 total unrelated AEs (856 for Irrisept & 952 for SoC), 35 unlikely related AEs (30 for Irrisept & 5 for SoC), 13 possibly related AEs (8 for Irrisept & 5 for SoC) and 0 probably & definitely related AEs (0 for Irrisept & SoC). | Posted | Number | Device-related AEs | up to 30 +/- 3 days | Adverse Events | Adverse Events |
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| 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. | Device deficiencies were only reported for subjects randomized to Irrisept. Of the 294 subjects randomized to Irrisept, there were 43 device deficiencies. Device deficiencies were "any inadequacy of the medical device with respect to its identity, quality, durability, reliability, safety and/or performance". | Posted | Number | Number of Device Deficiencies | up to 30 +/- 3 days | Irrisept Device Deficiencies | Irrisept Device Deficiencies |
|
CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group & 3) categories of organ classes for all AEs & SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept & 962 for SoC. There were 220 & 194 Irrisept & SoC subjects, respectively, that had AEs/SAEs/ADEs.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Irrisept | Irrisept® was used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen for study protocol IRR-CT-901-2013-01. 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. | 7 | 294 | 63 | 294 | 157 | 294 |
| EG001 | Standard of Care (SoC) | 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. 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. | 8 | 298 | 93 | 298 | 101 | 298 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood/Lymphatic SAEs | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Cardiac SAEs | Cardiac disorders | Non-systematic Assessment |
| ||
| GI SAEs | Gastrointestinal disorders | Non-systematic Assessment |
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| General SAEs | General disorders | Non-systematic Assessment |
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| Hepatobiliary SAEs | Hepatobiliary disorders | Non-systematic Assessment |
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| Infection SAEs | Infections and infestations | Non-systematic Assessment |
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| Injury SAEs | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Metabolic SAEs | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Nervous System SAEs | Nervous system disorders | Non-systematic Assessment |
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| Psychiatric SAEs | Psychiatric disorders | Non-systematic Assessment |
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| Renal/Urinary SAEs | Renal and urinary disorders | Non-systematic Assessment |
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| Respiratory SAEs | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Vascular SAEs | Vascular disorders | Non-systematic Assessment |
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| Ear/Labyrinth SAEs | Ear and labyrinth disorders | Non-systematic Assessment |
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| Endocrine SAEs | Endocrine disorders | Non-systematic Assessment |
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| Ocular SAEs | Eye disorders | Non-systematic Assessment |
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| Immune System SAEs | Immune system disorders | Non-systematic Assessment |
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| Investigational SAEs | Investigations | Non-systematic Assessment |
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| Musculoskeletal SAEs | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Neoplasm SAEs | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Reproductive System SAEs | Reproductive system and breast disorders | Non-systematic Assessment |
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| Skin/Subcutaneous Tissue SAEs | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood/Lymphatic AEs | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Cardiac AEs | Cardiac disorders | Non-systematic Assessment |
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| Ear/Labyrinth AEs | Ear and labyrinth disorders | Non-systematic Assessment |
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| Endocrine AEs | Endocrine disorders | Non-systematic Assessment |
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| Ocular AEs | Eye disorders | Non-systematic Assessment |
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| GI AEs | Gastrointestinal disorders | Non-systematic Assessment |
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| General AEs | General disorders | Non-systematic Assessment |
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| Hepatobiliary AEs | Hepatobiliary disorders | Non-systematic Assessment |
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| Infection AEs | Infections and infestations | Non-systematic Assessment |
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| Injury AEs | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Investigational AEs | Investigations | Non-systematic Assessment |
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| Metabolic AEs | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Musculoskeletal AEs | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Neoplasm AEs | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Nervous System AEs | Nervous system disorders | Non-systematic Assessment |
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| Psychiatric AEs | Psychiatric disorders | Non-systematic Assessment |
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| Renal/Urinary AEs | Renal and urinary disorders | Non-systematic Assessment |
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| Reproductive System AEs | Reproductive system and breast disorders | Non-systematic Assessment |
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| Respiratory AEs | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Skin/Subcutaneous Tissue AEs | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Vascular AEs | Vascular disorders | Non-systematic Assessment |
| ||
| Adverse Device Effects | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Irrimax Corporation | 770-807-3355 | cs@irrisept.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 26, 2021 | Mar 1, 2023 | SAP_001.pdf |
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| OG001 |
| Standard of Care (SoC) |
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. 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. |
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