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Recruiting NCT06339203

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

No phase Interventional Cesarean Section Complications Cesarean Section; Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Irrisept, Normal Saline.
Who it may be relevant to
Registry conditions: Cesarean Section Complications, Cesarean Section; Infection. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Device Irrisept
    450ml low concentration (0.05%) Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water
  • Drug Normal Saline
    450mL

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Loma Linda University — Loma Linda

Identifiers

NCT: NCT06339203 · 5240002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗