Wound Irrigation With Saline Versus Hypodilute-chlorhexidine After Cesarean Section (WISHES Study)

Not Applicable

Recruiting

• Conditions: Cesarean Section Complications; Cesarean Section; Infection
• Interventions: Device: Irrisept; Drug: Normal Saline

• Registration Number: NCT06339203
• Lead Sponsor: Loma Linda University

Brief Summary

This investigator-initiated, open-label, randomized controlled trial will explore the effects of two treatment arms, comparing standard treatment with normal saline against Irrisept, a jet lavage solution containing a low concentration of Chlorhexidine Gluconate (CHG) at 0.05% in 99.95% sterile water for irrigation. The study aims to evaluate the impact on postoperative wound healing in patients who have undergone cesarean delivery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-25
• Study First Submitted QC: 2024-03-25
• Study First Posted: 2024-04-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-05
• Study Start: 2025-04
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• Age 18 or older
• Singleton pregnancy
• Planned cesarean delivery at gestational age 37 weeks or later at Loma Linda University Children's Hospital
• Planned post-operative follow up with Loma Linda OBGYN
• Speak English or Spanish
• At least one of the following medical complications: Obesity BMI>= 30kg/m2, Diabetes, Spontaneous rupture of membranes, Intraamniotic infection

Exclusion Criteria

• Emergency cesarean delivery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Irrisept	Irrisept	The experimental arm will receive irrigation solution Irrisept administered through a proprietary bottle (jet lavage) following the closure of the fascia in Cesarean section.
Normal Saline	Normal Saline	The active comparator arm will receive the standard of care irrigation solution, normal saline, administered via standard pour over following the closure of the fascia in Cesarean section.

Primary Outcome Measures

Name	Time	Method
Composite wound evaluation scale after caesarean delivery	Up to 8 weeks postop	Wound Evaluation scale will be used to evaluate appropriate healing in the following categories: redness, bruising, discharge, tissue breakdown, wound infection

Trial Locations

Locations (1)

Loma Linda University; 🇺🇸 Loma Linda, California, United States