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

NCT02255487 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 627

Last updated 2022-05-24

Study results available
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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.

Conditions

  • Surgical Site Infection

Interventions

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.

Sponsors & Collaborators

  • Irrimax Corporation

    lead INDUSTRY

Principal Investigators

  • Donald Fry, MD · Michael Pine Associates

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-18
Primary Completion
2017-03-13
Completion
2017-03-13
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02255487 on ClinicalTrials.gov