Irrisept Versus Standard of Care in the Prevention of Surgical Site Infections

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase IV, Multicenter, Prospective, Randomized, Controlled Clinical Study to Compare the Irrisept System Versus Standard of Care (SoC) on the Prevalence of Surgical Site Infections in Patients With Abdominal Trauma or Acute Surgical Abdomen

Conditions
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Surgical Site Infection

Intervention / Treatment
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* Device: IrriSept System
* Other: No Intervention - Standard of Care (SoC) only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is male or female, 18 years of age or older Has provided written informed consent or has surrogate consent provided by a Legally Authorized Representative (LAR) Has experienced abdominal trauma, blunt or penetrating, requiring open abdominal laparotomy with primary closure or Has experienced acute surgical abdomen requiring open abdominal laparotomy with primary closure Exclusion Criteria: Known allergy to Chlorhexidine Gluconate (CHG) Estimated Abbreviated Injury Scale (AIS) score of six (6) at the time of surgery, for all trauma patients 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.) Female volunteers who are pregnant and/or breast feeding Damage control laparotomy Abdominal incision created prior to operating room (i.e. incision made in trauma bay to cross clamp the aorta) Currently enrolled in an ongoing, interventional, randomized clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The randomization methodology was controlled by the site.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IrriSept System<br>IrriSept device used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen | Device: IrriSept System<br>* 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.<br>|
| Active Comparator: Standard of Care (SoC) only<br>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<br>* Institution will provide routine Standard of Care (SoC) as surgical preparation for subjects with abdominal trauma or acute surgical abdomen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |