NCT02255487

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 627 (actual)
• Sponsor: Irrimax Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgical Site Infection

Interventions

Type	Name	Description
DEVICE	IrriSept 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.
OTHER	No 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.

Timeline

• Start date: 2015-02-18
• Primary completion: 2017-03-13
• Completion: 2017-03-13
• First posted: 2014-10-02
• Last updated: 2022-05-24
• Results posted: 2022-05-24

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated device study