Cesarean Section Complications, Cesarean Section; Infection
Conditions
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.
Interventions
DEVICEIrrisept
450ml low concentration (0.05%) Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water
DRUGNormal Saline
450mL
Sponsors
Loma Linda University
Irrimax Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTNikia Gray-Hutto, AS
CONTACTAshra Denise Tugung, BS
PRINCIPAL_INVESTIGATORRuofan Yao, MD, MPH
Loma Linda University
Outcome results
None listed