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The study was terminated early after the Interim Analysis due, in part, to issues with the accuracy and completeness of the data collected.
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The purpose of this study was to compare the rate of surgical site infections in patients randomized to Irrisept versus SoC, who had an open abdominal laparotomy for abdominal trauma or acute surgical abdomen.
The trial was explained to potential subjects, the informed consent was completed and and eligibility was verified. After this, the subjects were randomized to Irrisept or SoC and an open abdominal laparotomy with primary closure due to (1) blunt or penetrating abdominal trauma or (2) acute surgical abdomen was performed. The follow-up visit was performed approximately 30 days later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IrriSept System | Experimental | IrriSept device used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen |
|
| Standard of Care (SoC) only | Active Comparator | Institution will provide routine Standard of Care (SoC) surgical preparation for subjects with abdominal trauma or acute surgical abdomen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IrriSept System | Device | The IrriSept system consists of two containers: Step1, a sterile bottle of 450 mL 0.05% Chlorhexidine Gluconate in 99.95% water and Step 2, a sterile bottle of 450 mL of sterile 0.9% Normal Saline. Step 1 and Step 2 are identical in shape and size, with a clear distinction in labeling between. Their unique design allows the solutions to be delivered under the ideal pressure as determined by the surgeon via manual compression for wound and surgical irrigation. Subjects randomized to the IrriSept system will receive irrigation per the provided Instructions for use; those randomized to Standard of Care will receive routine care per discretion of the investigator and in accordance with the institution's guidelines, which may or may not include some other type of irrigation. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Subjects With Surgical Site Infections (SSI) | The primary endpoint was the rate of SSIs observed 30 days from the date of the index operation. | 30 (+/- 3) days post-surgical procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Readmission Rates | A secondary endpoint was the rate of Irrisept versus SoC subjects that required hospital readmission due to SSIs. | 30 (+/- 3) days post-surgical procedure |
| Hospital Costs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald Fry, MD | Michael Pine Associates | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Arizona | Tucson | Arizona | 85724 | United States | ||
| The University of Southern California, USC Medical Center |
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The planned sample size was 1100 screened, 650 completed & 600 evaluated. However, the study was terminated early after the interim analysis due, in part, to issues with the accuracy and completeness of the data collected. There were 627 consented and 617 randomized subjects. The intent-to-treat (ITT) population was defined as all randomized subjects. Of these, 309 were randomized to Irrisept and 308 to Standard of Care.
From 2015 to 2017, patients with abdominal trauma or acute surgical abdomen were recruited from participating research sites' universities, hospitals and/or emergency departments.
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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 consists of two containers: (1) a sterile bottle of 450 mL of 0.05% Chlorhexidine Gluconate (CHG) in 99.95% sterile water and (2) a sterile bottle of 450 mL of sterile 0.9% normal saline. |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 10, 2015 |
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The randomization methodology was controlled by the site.
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|
| No Intervention - Standard of Care (SoC) only | Other | Institution will provide routine Standard of Care (SoC) as surgical preparation for subjects with abdominal trauma or acute surgical abdomen. |
|
A secondary endpoint was the estimated hospital cost to charge ratio between Irrisept and SoC subjects. No data was collected towards this objective; thus, the success or failure of this endpoint was not assessed.
| 0 days |
| Length of Hospital Stay | A secondary endpoint was the length of hospital stay between subjects randomized to Irrisept versus SoC. | 30 (+/- 3) days post-surgical procedure |
| Los Angeles |
| California |
| 90033 |
| United States |
| Denver Health and Hospital Authority | Denver | Colorado | 80204 | United States |
| The University of South Florida, Tampa General Hospital | Tampa | Florida | 33606 | United States |
| The University of Iowa | Iowa City | Iowa | 52242 | United States |
| The University of Kentucky Research Foundation | Lexington | Kentucky | 40536 | United States |
| The University of Maryland, Baltimore | Baltimore | Maryland | 21201 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| Saint Louis University | St Louis | Missouri | 63110 | United States |
| The University of Cincinnati Health | Cincinnati | Ohio | 45267 | United States |
| The MetroHealth System | Cleveland | Ohio | 73160 | United States |
| Regional One Health Research Institute | Memphis | Tennessee | 38163 | United States |
| The University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| The University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| The University of Washington, Harborview Medical Center | Seattle | Washington | 98104 | United States |
| The Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| FG001 |
| Standard of Care (SoC) |
For subjects randomized to the control group, any Standard of Care (SoC) irrigation solution, preferred by the site, was used during the surgical procedure. |
| Modified Intent to Treat (mITT) |
|
| COMPLETED |
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| NOT COMPLETED |
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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. |
| BG001 | Standard of Care (SoC) | For subjects randomized to the control group, any SoC irrigation solution, preferred by the site, was used during the surgical procedure. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m2 |
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| Number of Participants By Surgical Case Type | Count of Participants | Participants |
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| Average Height | Mean | Standard Deviation | cm |
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| Average Weight | Mean | Standard Deviation | kg |
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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 | Percent of Subjects With Surgical Site Infections (SSI) | The primary endpoint was the rate of SSIs observed 30 days from the date of the index operation. | Data is from the percentage of subjects that reported an SSI for the mITT subject populations. | Posted | Count of Participants | Participants | 30 (+/- 3) days post-surgical procedure |
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| Secondary | Hospital Readmission Rates | A secondary endpoint was the rate of Irrisept versus SoC subjects that required hospital readmission due to SSIs. | Data is from the percentage of subjects that reported hospital readmission, due to an SSI, for the mITT subject populations. | Posted | Count of Participants | Participants | 30 (+/- 3) days post-surgical procedure |
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| Secondary | Hospital Costs | A secondary endpoint was the estimated hospital cost to charge ratio between Irrisept and SoC subjects. No data was collected towards this objective; thus, the success or failure of this endpoint was not assessed. | No data was collected for either randomization group, towards this objective. Therefore, the success or failure of this endpoint was not assessed. | Posted | 0 days |
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| Secondary | Length of Hospital Stay | A secondary endpoint was the length of hospital stay between subjects randomized to Irrisept versus SoC. | Data is from the average number of days in the hospital for the mITT subject populations. | Posted | Mean | Standard Deviation | number of days | 30 (+/- 3) days post-surgical procedure |
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Adverse events were not collected.
Adverse events were not collected.
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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 | For subjects randomized to the investigational group, Irrisept was used during the surgical procedure, per the provided instructions for use. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Standard of Care (SoC) | For subjects randomized to the control group, any Standard of Care (SoC) irrigation solution, preferred by the site, was used during the surgical procedure. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chevy Brown, Clinical Trials Manager | Irrimax Corporation | 770-807-3355 | 15 | chevy.brown@irrisept.com |
| Oct 15, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012847 | Single Person |
| ID | Term |
|---|---|
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D012959 | Socioeconomic Factors |
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| Male |
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| American Indian or Alaska Native |
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| Asian |
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| Black or African American |
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| Native Hawaiian or other Pacific Islander |
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| Mixed Race |
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| Other |
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| Unknown |
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| Trauma |
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| Missing |
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