Irrisept in Emergency General Surgery Patients

NCT07048899 | Enrolling By Invitation Phase 4 DMC FDA Drug

• 1 other identifier: 2024-122
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Emergency Surgery; Surgical Site Infections

Keywords

Irrisept; Surgical Irrigation; Surgical Site Infection; Emergency General Surgery; Acute Care Surgery; Normal Saline Irrigation

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infection Rate

  Determine if the rate of SSI is different

  Time of enrollment to 30 days

Secondary Outcomes (3)

• Length of Stay

  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 of enrollment to 30 days

• Readmission Rates due to SSI

  From day of surgery to 30 days

Study Arms (2)

Standard of Care (Normal Saline)

PLACEBO COMPARATOR

Irrigation with Normal Saline

Drug: Normal Saline

Intervention (Irrisept)

EXPERIMENTAL

Irrigation with Irrisept

Drug: Chlorhexidine

Interventions

Chlorhexidine DRUG

Intraperitoneal irrigation with Irrisept solution

Also known as: Irrisept

Intervention (Irrisept)

Normal Saline DRUG

Intraperitoneal irrigation with normal saline

Also known as: Standard of Care

Standard of Care (Normal Saline)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center at Tyler: lead
• Irrimax Corporation: collaborator

Study Sites (1)

UT Health Tyler

Tyler, Texas, 75701, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Chlorhexidine; Saline Solution; Standard of Care

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgery Resident

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: July 3, 2025
• Study Start: September 4, 2024
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Beginning after completion of project and ending 5 years after publication of results

Locations

US (1)