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Recruiting

NCT Number: NCT06339203

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

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.

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Key information

Conditions

Cesarean Section Complications Cesarean Section; Infection Infections

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University

Loma Linda, California, 92354, United States

Location status: Recruiting

Location contact

Nikia Gray Hutto, AS

CONTACT

[email protected]

909-558-4000 ext. 44428

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Irrisept

Device

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

normal saline

Drug

450mL

Primary outcomes

  1. Composite wound evaluation scale after caesarean delivery

    Time frame: Up to 8 weeks postop

    Wound Evaluation scale will be used to evaluate appropriate healing in the following categories: redness, bruising, discharge, tissue breakdown, wound infection

Study contacts

Contact information is provided by the study sponsor or research team.

Ashra Denise Tugung, BS

CONTACT

[email protected]

9096515580

Nikia Gray-Hutto, AS

CONTACT

[email protected]

9095584000 ext. 44428

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Collaborators

  • Irrimax Corporation

Registry information

Official study title

Wound Irrigation With Saline Versus Hypodilute-chlorhexidine After Cesarean Section: a Randomized Clinical Trial (WISHES Study)

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2024
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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