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

NCT ID: NCT06339203

Last Updated: 2025-06-05

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-05

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cesarean Section Complications Cesarean Section; Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

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.

Group Type EXPERIMENTAL

Irrisept

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Normal Saline

Intervention Type DRUG

450mL

Interventions

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Irrisept

450ml low concentration (0.05%) Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water

Intervention Type DEVICE

Normal Saline

450mL

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Irrimax Corporation

INDUSTRY

Sponsor Role collaborator

Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nikia Gray-Hutto, AS

Role: CONTACT

9095584000 ext. 44428

Ashra Denise Tugung, BS

Role: CONTACT

9096515580

Facility Contacts

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Nikia Gray Hutto, AS

Role: primary

909-558-4000 ext. 44428

Other Identifiers

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5240002

Identifier Type: -

Identifier Source: org_study_id

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