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

Irrimax

Status: Terminated

Conditions: Surgical Site Infection

Treatments: Device: IrriSept System; Other: No Intervention - Standard of Care (SoC) only

Study type: Interventional

Funder types: Industry

Identifiers

NCT02255487

IRR-CT-901-2013-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 627 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

627 participants in 2 patient groups

IrriSept System

Experimental group

Description:

IrriSept device used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen

Treatment:

Device: IrriSept System

Standard of Care (SoC) only

Active Comparator group

Description:

Institution will provide routine Standard of Care (SoC) surgical preparation for subjects with abdominal trauma or acute surgical abdomen.

Treatment:

Other: No Intervention - Standard of Care (SoC) only