Wound Irrigation With Saline Versus Hypodilute-chlorhexidine After Cesarean Section (WISHES Study)
NCT ID: NCT06339203
Last Updated: 2025-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2024-06-05
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
Irrisept
450ml low concentration (0.05%) Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water
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.
Normal Saline
450mL
Interventions
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Irrisept
450ml low concentration (0.05%) Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water
Normal Saline
450mL
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Irrimax Corporation
INDUSTRY
Loma Linda University
OTHER
Responsible Party
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Principal Investigators
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Ruofan Yao, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Loma Linda University
Locations
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Loma Linda University
Loma Linda, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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5240002
Identifier Type: -
Identifier Source: org_study_id
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