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

Loma Linda University (LLU)

Status: Enrolling

Conditions: Cesarean Section Complications; Cesarean Section; Infection

Treatments: Device: Irrisept; Drug: Normal Saline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06339203

5240002

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Irrisept

Experimental group

Description:

The experimental arm will receive irrigation solution Irrisept administered through a proprietary bottle (jet lavage) following the closure of the fascia in Cesarean section.

Treatment:

Device: Irrisept

Normal Saline

Active Comparator group

Description:

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.

Treatment:

Drug: Normal Saline