Irrisept in Emergency General Surgery Patients

The University of Texas System (UT)

Status and phase: Invitation-only; Phase 4

Conditions: Emergency Surgery; Surgical Site Infections

Treatments: Drug: Chlorhexidine; Drug: Normal Saline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07048899

2024-122

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups, including a placebo group

Standard of Care (Normal Saline)

Placebo Comparator group

Description:

Irrigation with Normal Saline

Treatment:

Drug: Normal Saline

Intervention (Irrisept)

Experimental group

Description:

Irrigation with Irrisept

Treatment:

Drug: Chlorhexidine