NCT02255487TerminatedNot Applicable
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
Irrimax Corporation34 sites in 1 country627 target enrollmentStarted: February 18, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Irrimax Corporation
- Enrollment
- 627
- Locations
- 34
- Primary Endpoint
- Percent of Subjects With Surgical Site Infections (SSI)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Percent of Subjects With Surgical Site Infections (SSI)
Time Frame: 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 Outcomes
- Hospital Costs(0 days)
- Hospital Readmission Rates(30 (+/- 3) days post-surgical procedure)
- Length of Hospital Stay(30 (+/- 3) days post-surgical procedure)
Investigators
Study Sites (34)
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