Surgical Site Infection
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEIrriSept System
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.
OTHERNo Intervention - Standard of Care (SoC) only
Institution will provide routine Standard of Care (SoC) as surgical preparation for subjects with abdominal trauma or acute surgical abdomen.
Sponsors
Irrimax Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
The randomization methodology was controlled by the site.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Is male or female, 18 years of age or older 2. Has provided written informed consent or has surrogate consent provided by a Legally Authorized Representative (LAR) 3. Has experienced abdominal trauma, blunt or penetrating, requiring open abdominal laparotomy with primary closure or 4. Has experienced acute surgical abdomen requiring open abdominal laparotomy with primary closure
Exclusion criteria
1. Known allergy to Chlorhexidine Gluconate (CHG) 2. Estimated Abbreviated Injury Scale (AIS) score of six (6) at the time of surgery, for all trauma patients 3. American Society of Anesthesiologists Physical Status Classification (ASA) score of five (5) or greater (As ASA scoring is a subjective measure, if the PI finds the patient stable enough for study participation despite a score of 5, enrollment may continue.) 4. Female volunteers who are pregnant and/or breast feeding 5. Damage control laparotomy 6. Abdominal incision created prior to operating room (i.e. incision made in trauma bay to cross clamp the aorta) 7. Currently enrolled in an ongoing, interventional, randomized clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects With Surgical Site Infections (SSI) | 30 (+/- 3) days post-surgical procedure | The primary endpoint was the rate of SSIs observed 30 days from the date of the index operation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Readmission Rates | 30 (+/- 3) days post-surgical procedure | A secondary endpoint was the rate of Irrisept versus SoC subjects that required hospital readmission due to SSIs. |
| Hospital Costs | 0 days | 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. |
| Length of Hospital Stay | 30 (+/- 3) days post-surgical procedure | A secondary endpoint was the length of hospital stay between subjects randomized to Irrisept versus SoC. |
Countries
United States
Participant flow
Recruitment details
From 2015 to 2017, patients with abdominal trauma or acute surgical abdomen were recruited from participating research sites' universities, hospitals and/or emergency departments.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Irrisept For subjects randomized to the investigational group, Irrisept was used during the surgical procedure, per the provided instructions for use. | 293 |
| 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. | 291 |
| Total | 584 |
Baseline characteristics
| Characteristic | Irrisept | Total | Standard of Care (SoC) |
|---|---|---|---|
| Age, Customized Average Age (Years) | 49.1 years STANDARD_DEVIATION 18.7 | 49.6 years STANDARD_DEVIATION 17.9 | 50.1 years STANDARD_DEVIATION 17.1 |
| Average Height | 172.7 cm STANDARD_DEVIATION 19 | 171.4 cm STANDARD_DEVIATION 16.7 | 170.0 cm STANDARD_DEVIATION 14.4 |
| Average Weight | 85.2 kg STANDARD_DEVIATION 27.3 | 84.3 kg STANDARD_DEVIATION 26.6 | 83.4 kg STANDARD_DEVIATION 25.8 |
| Body Mass Index | 29.0 kg/m2 STANDARD_DEVIATION 10.9 | 29.2 kg/m2 STANDARD_DEVIATION 11.6 | 29.3 kg/m2 STANDARD_DEVIATION 12.2 |
| Number of Participants By Surgical Case Type Acute Surgical Abdomen | 180 Participants | 371 Participants | 191 Participants |
| Number of Participants By Surgical Case Type Missing | 5 Participants | 7 Participants | 2 Participants |
| Number of Participants By Surgical Case Type Trauma | 108 Participants | 206 Participants | 98 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 8 Participants | 11 Participants | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 75 Participants | 152 Participants | 77 Participants |
| Race/Ethnicity, Customized Mixed Race | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 5 Participants | 7 Participants | 2 Participants |
| Race/Ethnicity, Customized Unknown | 4 Participants | 8 Participants | 4 Participants |
| Race/Ethnicity, Customized White or Caucasian | 199 Participants | 401 Participants | 202 Participants |
| Region of Enrollment United States | 293 participants | 584 participants | 291 participants |
| Sex: Female, Male Female | 103 Participants | 224 Participants | 121 Participants |
| Sex: Female, Male Male | 190 Participants | 360 Participants | 170 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 30 (+/- 3) days post-surgical procedure
Population: Data is from the percentage of subjects that reported an SSI for the mITT subject populations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Irrisept | Percent of Subjects With Surgical Site Infections (SSI) | 48 Participants |
| Standard of Care (SoC) | Percent of Subjects With Surgical Site Infections (SSI) | 32 Participants |
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.
Time frame: 0 days
Population: No data was collected for either randomization group, towards this objective. Therefore, the success or failure of this endpoint was not assessed.
Secondary
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
Population: Data is from the percentage of subjects that reported hospital readmission, due to an SSI, for the mITT subject populations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Irrisept | Hospital Readmission Rates | 13 Participants |
| Standard of Care (SoC) | Hospital Readmission Rates | 13 Participants |
Secondary
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
Population: Data is from the average number of days in the hospital for the mITT subject populations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Irrisept | Length of Hospital Stay | 11.6 number of days | Standard Deviation 24.8 |
| Standard of Care (SoC) | Length of Hospital Stay | 12.0 number of days | Standard Deviation 23.4 |