Wound Irrigation With Saline Versus Hypodilute-chlorhexidine After Cesarean Section (WISHES Study)
1 other identifier
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2024
CompletedFirst Posted
Study publicly available on registry
April 1, 2024
CompletedStudy Start
First participant enrolled
June 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
June 5, 2025
June 1, 2025
2.5 years
March 25, 2024
June 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Composite wound evaluation scale after caesarean delivery
Wound Evaluation scale will be used to evaluate appropriate healing in the following categories: redness, bruising, discharge, tissue breakdown, wound infection
Up to 8 weeks postop
Study Arms (2)
Irrisept
EXPERIMENTALThe experimental arm will receive irrigation solution Irrisept administered through a proprietary bottle (jet lavage) following the closure of the fascia in Cesarean section.
Normal Saline
ACTIVE COMPARATORThe 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.
Interventions
450ml low concentration (0.05%) Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water
Eligibility Criteria
You 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 may not qualify if:
- Emergency cesarean delivery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Loma Linda Universitylead
- Irrimax Corporationcollaborator
Study Sites (1)
Loma Linda University
Loma Linda, California, 92354, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ruofan Yao, MD, MPH
Loma Linda University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2024
First Posted
April 1, 2024
Study Start
June 5, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
June 5, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share