Recruiting

Saline vs. Hypodilute-Chlorhexidine

Sponsor:

Loma Linda University

Code:

NCT06339203

Conditions

Cesarean Section Complications

Cesarean Section; Infection

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Irrisept

Normal Saline

Study Details

Brief 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

Study ID

NCT06339203

Start date

Jun 5, 2024

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Irrisept

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

Normal Saline

450mL

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Nikia Gray-Hutto, AS

9095584000nhutto@llu.edu

Ashra Denise Tugung, BS

9096515580atugung@llu.edu

Locations

Loma Linda University

Recruiting

Loma Linda, California, United States, 92354

Contacts

Nikia Gray Hutto, AS

909-558-4000nhutto@llu.edu

More Information

Sponsor

Loma Linda University

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Loma Linda University on 2026-06-08.