Trial Outcomes & Findings for Irrisept Versus Standard of Care in the Prevention of Surgical Site Infections (NCT NCT02255487)
NCT ID: NCT02255487
Last Updated: 2022-05-24
Results Overview
The primary endpoint was the rate of SSIs observed 30 days from the date of the index operation.
TERMINATED
NA
627 participants
30 (+/- 3) days post-surgical procedure
2022-05-24
Participant Flow
From 2015 to 2017, patients with abdominal trauma or acute surgical abdomen were recruited from participating research sites' universities, hospitals and/or emergency departments.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
309
|
308
|
|
Overall Study
Modified Intent to Treat (mITT)
|
293
|
291
|
|
Overall Study
COMPLETED
|
218
|
230
|
|
Overall Study
NOT COMPLETED
|
91
|
78
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Irrisept Versus Standard of Care in the Prevention of Surgical Site Infections
Baseline characteristics by cohort
| Measure |
Irrisept
n=293 Participants
For subjects randomized to the investigational group, Irrisept was used during the surgical procedure, per the provided instructions for use.
|
Standard of Care (SoC)
n=291 Participants
For subjects randomized to the control group, any SoC irrigation solution, preferred by the site, was used during the surgical procedure.
|
Total
n=584 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Average Age (Years)
|
49.1 years
STANDARD_DEVIATION 18.7 • n=5 Participants
|
50.1 years
STANDARD_DEVIATION 17.1 • n=7 Participants
|
49.6 years
STANDARD_DEVIATION 17.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
190 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
360 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
199 Participants
n=5 Participants
|
202 Participants
n=7 Participants
|
401 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
75 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
293 participants
n=5 Participants
|
291 participants
n=7 Participants
|
584 participants
n=5 Participants
|
|
Body Mass Index
|
29.0 kg/m2
STANDARD_DEVIATION 10.9 • n=5 Participants
|
29.3 kg/m2
STANDARD_DEVIATION 12.2 • n=7 Participants
|
29.2 kg/m2
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Number of Participants By Surgical Case Type
Acute Surgical Abdomen
|
180 Participants
n=5 Participants
|
191 Participants
n=7 Participants
|
371 Participants
n=5 Participants
|
|
Number of Participants By Surgical Case Type
Trauma
|
108 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
|
Number of Participants By Surgical Case Type
Missing
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Average Height
|
172.7 cm
STANDARD_DEVIATION 19.0 • n=5 Participants
|
170.0 cm
STANDARD_DEVIATION 14.4 • n=7 Participants
|
171.4 cm
STANDARD_DEVIATION 16.7 • n=5 Participants
|
|
Average Weight
|
85.2 kg
STANDARD_DEVIATION 27.3 • n=5 Participants
|
83.4 kg
STANDARD_DEVIATION 25.8 • n=7 Participants
|
84.3 kg
STANDARD_DEVIATION 26.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: 30 (+/- 3) days post-surgical procedurePopulation: Data is from the percentage of subjects that reported an SSI for the mITT subject populations.
The primary endpoint was the rate of SSIs observed 30 days from the date of the index operation.
Outcome measures
| Measure |
Irrisept
n=293 Participants
For subjects randomized to the investigational group, Irrisept was used during the surgical procedure, per the provided instructions for use.
|
Standard of Care (SoC)
n=291 Participants
For subjects randomized to the control group, any SoC irrigation solution, preferred by the site, was used during the surgical procedure.
|
|---|---|---|
|
Percent of Subjects With Surgical Site Infections (SSI)
|
48 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 30 (+/- 3) days post-surgical procedurePopulation: Data is from the percentage of subjects that reported hospital readmission, due to an SSI, for the mITT subject populations.
A secondary endpoint was the rate of Irrisept versus SoC subjects that required hospital readmission due to SSIs.
Outcome measures
| Measure |
Irrisept
n=293 Participants
For subjects randomized to the investigational group, Irrisept was used during the surgical procedure, per the provided instructions for use.
|
Standard of Care (SoC)
n=291 Participants
For subjects randomized to the control group, any SoC irrigation solution, preferred by the site, was used during the surgical procedure.
|
|---|---|---|
|
Hospital Readmission Rates
|
13 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 0 daysPopulation: No data was collected for either randomization group, towards this objective. Therefore, the success or failure of this endpoint was not assessed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 (+/- 3) days post-surgical procedurePopulation: Data is from the average number of days in the hospital for the mITT subject populations.
A secondary endpoint was the length of hospital stay between subjects randomized to Irrisept versus SoC.
Outcome measures
| Measure |
Irrisept
n=293 Participants
For subjects randomized to the investigational group, Irrisept was used during the surgical procedure, per the provided instructions for use.
|
Standard of Care (SoC)
n=291 Participants
For subjects randomized to the control group, any SoC irrigation solution, preferred by the site, was used during the surgical procedure.
|
|---|---|---|
|
Length of Hospital Stay
|
11.6 number of days
Standard Deviation 24.8
|
12.0 number of days
Standard Deviation 23.4
|
Adverse Events
Irrisept
Standard of Care (SoC)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Chevy Brown, Clinical Trials Manager
Irrimax Corporation
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place