Clinical trial NCT02255487: Irrisept Versus Standard of Care in the Prevention of Surgical Site Infections
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgical Site Infection
Lead sponsor: Irrimax Corporation
Sponsor class: INDUSTRY
First posted: 2014-10-02
Enrollment: 627
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The randomization methodology was controlled by the site.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent of Subjects With Surgical Site Infections (SSI)
timeFrame: 30 (+/- 3) days post-surgical procedure
Secondary outcomes:
measure: Hospital Readmission Rates
timeFrame: 30 (+/- 3) days post-surgical procedure
measure: Hospital Costs
timeFrame: 0 days
measure: Length of Hospital Stay
timeFrame: 30 (+/- 3) days post-surgical procedure
Other outcomes:
Locations:
city: Tucson
country: United States
facility: The University of Arizona
state: Arizona
city: Los Angeles
country: United States
facility: The University of Southern California, USC Medical Center
state: California
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
city: Tampa
country: United States
facility: The University of South Florida, Tampa General Hospital
state: Florida
city: Iowa City
country: United States
facility: The University of Iowa
state: Iowa
city: Lexington
country: United States
facility: The University of Kentucky Research Foundation
state: Kentucky
city: Baltimore
country: United States
facility: The University of Maryland, Baltimore
state: Maryland
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Cincinnati
country: United States
facility: The University of Cincinnati Health
state: Ohio
city: Cleveland
country: United States
facility: The MetroHealth System
state: Ohio
city: Memphis
country: United States
facility: Regional One Health Research Institute
state: Tennessee
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
city: Seattle
country: United States
facility: The University of Washington, Harborview Medical Center
state: Washington
city: Milwaukee
country: United States
facility: The Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Michael Pine Associates
name: Donald Fry, MD
role: STUDY_DIRECTOR
References: