An interventional study of IrriSept System and No Intervention - Standard of Care (SoC) only in Surgical Site Infection, sponsored by Irrimax Corporation. Terminated at 17 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-24.
Sponsored by Irrimax Corporation · Not applicable, Interventional, and Other
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.
687 studies on the registry are indexed under Surgical Wound Infection; 142 are open to participants now.
This study's enrollment of 627 is above the median of 200 across 526 interventional studies indexed under Surgical Wound Infection.
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Exclusion Criteria:
IrriSept device used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen
Device: IrriSept System
Institution will provide routine Standard of Care (SoC) surgical preparation for subjects with abdominal trauma or acute surgical abdomen.
Other: No Intervention - Standard of Care (SoC) only
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.
Institution will provide routine Standard of Care (SoC) as surgical preparation for subjects with abdominal trauma or acute surgical abdomen.
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.
Time frame: 30 (+/- 3) days post-surgical procedure
Hospital Readmission Rates
A secondary endpoint was the rate of Irrisept versus SoC subjects that required hospital readmission due to SSIs.
Time frame: 30 (+/- 3) days post-surgical procedure
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.
Time frame: 0 days
Length of Hospital Stay
A secondary endpoint was the length of hospital stay between subjects randomized to Irrisept versus SoC.
Time frame: 30 (+/- 3) days post-surgical procedure
From 2015 to 2017, patients with abdominal trauma or acute surgical abdomen were recruited from participating research sites' universities, hospitals and/or emergency departments.
| Milestone | Irrisept | Standard of Care (SoC) |
|---|---|---|
| Started | 309 | 308 |
| Modified intent to treat (mitt) | 293 | 291 |
| Completed | 218 | 230 |
| Not completed | 91 | 78 |
The primary endpoint was the rate of SSIs observed 30 days from the date of the index operation.
| Participants | Irrisept | Standard of Care (SoC) |
|---|---|---|
| Percent of Subjects With Surgical Site Infections (SSI) | 48 | 32 |
A secondary endpoint was the rate of Irrisept versus SoC subjects that required hospital readmission due to SSIs.
| Participants | Irrisept | Standard of Care (SoC) |
|---|---|---|
| Hospital Readmission Rates | 13 | 13 |
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 measurements were reported for this outcome.
A secondary endpoint was the length of hospital stay between subjects randomized to Irrisept versus SoC.
| number of days | Irrisept | Standard of Care (SoC) |
|---|---|---|
| Length of Hospital Stay | 11.6 ± 24.8 | 12.0 ± 23.4 |
Collected over Adverse events were not collected.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Irrisept | — | — | — |
| Standard of Care (SoC) | — | — | — |
| Age, Customized(years) | Irrisept | Standard of Care (SoC) | Total |
|---|---|---|---|
| Average Age (Years) | 49.1 ± 18.7 | 50.1 ± 17.1 | 49.6 ± 17.9 |
| Sex: Female, Male(Participants) | Irrisept | Standard of Care (SoC) | Total |
|---|---|---|---|
| Female | 103 | 121 | 224 |
| Male | 190 | 170 | 360 |
| Race/Ethnicity, Customized(Participants) | Irrisept | Standard of Care (SoC) | Total |
|---|---|---|---|
| White or Caucasian | 199 | 202 | 401 |
| American Indian or Alaska Native | 2 | 1 | 3 |
| Asian | 8 | 3 | 11 |
| Black or African American | 75 | 77 | 152 |
| Native Hawaiian or other Pacific Islander | 0 | 1 | 1 |
| Mixed Race | 0 | 1 | 1 |
| Other | 5 | 2 | 7 |
| Unknown | 4 | 4 | 8 |
| Region of Enrollment(participants) | Irrisept | Standard of Care (SoC) | Total |
|---|---|---|---|
| United States | 293 | 291 | 584 |
| Body Mass Index(kg/m2) | Irrisept | Standard of Care (SoC) | Total |
|---|---|---|---|
| Mean | 29.0 ± 10.9 | 29.3 ± 12.2 | 29.2 ± 11.6 |
| Number of Participants By Surgical Case Type(Participants) | Irrisept | Standard of Care (SoC) | Total |
|---|---|---|---|
| Acute Surgical Abdomen | 180 | 191 | 371 |
| Trauma | 108 | 98 | 206 |
| Missing | 5 | 2 | 7 |
| Average Height(cm) | Irrisept | Standard of Care (SoC) | Total |
|---|---|---|---|
| Mean | 172.7 ± 19.0 | 170.0 ± 14.4 | 171.4 ± 16.7 |
| Average Weight(kg) | Irrisept | Standard of Care (SoC) | Total |
|---|---|---|---|
| Mean | 85.2 ± 27.3 | 83.4 ± 25.8 | 84.3 ± 26.6 |
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Irrimax Corporation