Irrisept in Emergency General Surgery Patients

June 29, 2025 updated by: Brittany Wagner, The University of Texas Health Science Center at Tyler

Effects of Irrisept Irrigation in Emergency General Surgery Cases on SSI Rates

This is a single institution, randomized study conducted to determine if irrigation with Irrisept in emergency general surgery patients results in lower surgical site infections compared to normal saline irrigation.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Tyler, Texas, United States, 75701
        • UT Health Tyler

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All patients (>18 years old at time of enrollment) who are hospitalized at UT Tyler and undergo an open (or conversion to open) wound class 2-4 surgical procedure for an emergent surgical condition.

Exclusion Criteria:

  • Those <18 years of age
  • Pressure wounds
  • Superficial abscesses (as primary diagnosis)
  • intra-abdominal abscess due to previous technical failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Standard of Care (Normal Saline)
Irrigation with Normal Saline
Drug: Normal Saline
Intraperitoneal irrigation with normal saline
Other Names:
  • Standard of Care
Experimental: Intervention (Irrisept)
Irrigation with Irrisept
Drug: Chlorhexidine
Intraperitoneal irrigation with Irrisept solution
Other Names:
  • Irrisept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Site Infection Rate
Time Frame: Time of enrollment to 30 days
Determine if the rate of SSI is different
Time of enrollment to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Stay
Time Frame: From date of admission until date of discharge from the hospital, assessed up to 30 days post-operatively
Number of days admitted to hospital
From date of admission until date of discharge from the hospital, assessed up to 30 days post-operatively
Incidence of SSI and surgical wound class with the use of Irrisept
Time Frame: Time of enrollment to 30 days
Correlation between surgical wound class and the use of Irrisept on the incidence of SSI
Time of enrollment to 30 days
Readmission Rates due to SSI
Time Frame: From day of surgery to 30 days
How often a patient has to be re-admitted to the hospital for a surgical site infection
From day of surgery to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at Tyler

Collaborators

Irrimax Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

June 11, 2025

First Submitted That Met QC Criteria

June 29, 2025

First Posted (Actual)

July 3, 2025

Study Record Updates

Last Update Posted (Actual)

July 3, 2025

Last Update Submitted That Met QC Criteria

June 29, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Only IPD used in the result publication

IPD Sharing Time Frame

Beginning after completion of project and ending 5 years after publication of results

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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