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

Surgical Site Infection Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02255487
Study type Interventional
Source Irrimax Corporation
Contact
Status Terminated
Phase N/A
Start date February 18, 2015
Completion date March 13, 2017
View Details
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