MedTrace Logo

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

NCT06339203 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-06-05

No results posted yet for this study

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.

Conditions

  • Cesarean Section Complications
  • Cesarean Section; Infection

Interventions

DEVICE

Irrisept

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

DRUG

Normal Saline

450mL

Sponsors & Collaborators

  • Irrimax Corporation

    collaborator INDUSTRY

  • Loma Linda University

    lead OTHER

Principal Investigators

  • Ruofan Yao, MD, MPH · Loma Linda University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-05
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06339203 on ClinicalTrials.gov