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

Part of paid clinical trials in Loma Linda, California.

Sponsor
Loma Linda University
Study ID
NCT06339203
Status
Recruiting
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Conditions

  • Cesarean Section Complications
  • Cesarean Section; Infection

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Irrisept — DEVICE
    450ml low concentration (0.05%) Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water
  • Normal Saline — DRUG
    450mL

Study Details

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.

Key Dates

Start date
Jun 5, 2024
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.
  • 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.

Primary Outcome Measure

Composite wound evaluation scale after caesarean delivery [ Time Frame: Up to 8 weeks postop ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Loma Linda UniversityLoma LindaCalifornia92354
Nikia Gray Hutto, AS
[email protected]
909-558-4000

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Loma Linda University· Loma Linda, CA

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