Wound Irrigation With Saline Versus Hypodilute-chlorhexidine After Cesarean Section: a Randomized Clinical Trial (WISHES Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Loma Linda University
- Enrollment
- 400
- Locations
- 2
- Primary Endpoint
- Composite wound evaluation scale after caesarean delivery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Irrisept (Device)
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.
Intervention: Normal Saline (Drug)
Outcomes
Primary Outcomes
Composite wound evaluation scale after caesarean delivery
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported