RecruitingNot ApplicableNCT06339203

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

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


Sponsor

Loma Linda University

Enrollment

400 participants

Start Date

Jun 5, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

  • 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 Criteria1

  • Emergency cesarean delivery

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Interventions

DEVICEIrrisept

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

DRUGNormal Saline

450mL


Locations(1)

Loma Linda University

Loma Linda, California, United States

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NCT06339203


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