Cesarean Section Complications Clinical Trial
Official title:
Intraoperative Wound Irrigation in Cesarean Section: A Randomized Control Trial
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.
Status | Not yet recruiting |
Enrollment | 400 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Loma Linda University | Loma Linda | California |
Lead Sponsor | Collaborator |
---|---|
Loma Linda University | Irrimax Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite wound evaluation after caesarean delivery | Redness, bruising, discharge, tissue breakdown | Up to 8 weeks postop |
Status | Clinical Trial | Phase | |
---|---|---|---|
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