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Irrisept in Emergency General Surgery Patients

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

Status
Enrolling by invitation
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07048899
Enrollment
400
Registered
2025-07-03
Start date
2024-09-04
Completion date
2026-04-30
Last updated
2025-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergency Surgery, Surgical Site Infections

Keywords

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

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.

Interventions

DRUGChlorhexidine

Intraperitoneal irrigation with Irrisept solution

DRUGNormal Saline

Intraperitoneal irrigation with normal saline

Sponsors

Irrimax Corporation
CollaboratorINDUSTRY
The University of Texas Health Science Center at Tyler
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Surgical Site Infection RateTime of enrollment to 30 daysDetermine if the rate of SSI is different

Secondary

MeasureTime frameDescription
Length of StayFrom date of admission until date of discharge from the hospital, assessed up to 30 days post-operativelyNumber of days admitted to hospital
Incidence of SSI and surgical wound class with the use of IrriseptTime of enrollment to 30 daysCorrelation between surgical wound class and the use of Irrisept on the incidence of SSI
Readmission Rates due to SSIFrom day of surgery to 30 daysHow often a patient has to be re-admitted to the hospital for a surgical site infection

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026