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Enrolling by Invitation

NCT Number: NCT07048899

Irrisept in Emergency General Surgery Patients

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.

Enrolling by Invitation

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Key information

Conditions

Emergency Surgery Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Site Infections Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UT Health Tyler

Tyler, Texas, 75701, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorhexidine

Drug

Intraperitoneal irrigation with Irrisept solution

Other names: Irrisept

normal saline

Drug

Intraperitoneal irrigation with normal saline

Other names: Standard of Care

Primary outcomes

  1. Surgical Site Infection Rate

    Time frame: Time of enrollment to 30 days

    Determine if the rate of SSI is different

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at Tyler

Other

Collaborators

  • Irrimax Corporation

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 3, 2025
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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