What this study is
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.
What's being tested
- Irrisept
Intervention · DEVICE
450ml low concentration (0.05%) Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water
- Normal Saline
Intervention · DRUG
450mL
Study details
- Official title
- Wound Irrigation With Saline Versus Hypodilute-chlorhexidine After Cesarean Section: a Randomized Clinical Trial (WISHES Study)
- Sponsor
- Loma Linda University
- Conditions
- Cesarean Section Complications · Cesarean Section; Infection
- Enrolling
- 400 people
- Starts
- 2024-06-05
- Est. completion
- 2026-12
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- Emergency cesarean delivery
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openLoma Linda University
Loma Linda, California, United States
- Nikia Gray Hutto, AS · Contact909-558-4000 ext. 44428nhutto@llu.edu
Recruiting
Study team
Sponsor
Loma Linda University
Study ID 5240002
Principal investigator
Ruofan Yao, MD, MPH
Loma Linda University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.