Wound Irrigation With Saline Versus Hypodilute-chlorhexidine After Cesarean Section (WISHES Study)

Purpose

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.

Conditions

  • Cesarean Section Complications
  • Cesarean Section; Infection

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Device: Irrisept
    450ml low concentration (0.05%) Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water
Active Comparator
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.
  • Drug: Normal Saline
    450mL

Recruiting Locations

Loma Linda University
Loma Linda, California 92354
Contact:
Nikia Gray Hutto, AS
909-558-4000
nhutto@llu.edu

More Details

NCT ID
NCT06339203
Status
Recruiting
Sponsor
Loma Linda University

Study Contact

Nikia Gray-Hutto, AS
9095584000
nhutto@llu.edu

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center