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NCT06339203 Clinical Trial

Intraoperative Wound Irrigation in Cesarean Section

Cesarean Section Complications Clinical Trial

Official title:
Intraoperative Wound Irrigation in Cesarean Section: A Randomized Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06339203
Other study ID # 5240002
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date December 2025

Study information
Verified date March 2024
Source Loma Linda University
Contact Nikia Gray-Hutto, AS
Phone 9095584000
Email nhutto@llu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Irrisept
450ml low concentration (0.05%) Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water
Drug:
• Normal Saline
450mL

Locations
Country Name City State
United States Loma Linda University Loma Linda California

Sponsors (2)
Lead Sponsor Collaborator
Loma Linda University Irrimax Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Composite wound evaluation after caesarean delivery Redness, bruising, discharge, tissue breakdown Up to 8 weeks postop
See also
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