Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery
Completed · Phase 4
Conditions studied: Cesarean Section Complications, Wound Breakdown, Wound Infection, Satisfaction, Surgical Wound Infection
In brief
This will be an open label pilot randomized controlled clinical trial. Women undergoing cesarean delivery will be randomized to have standard wound dressing care or chlorohexidine gluconate (CHG) impregnated wound dressing (ReliaTect™ Post-Op Dressing).
Key facts
- Study ID
- NCT03887299
- Run by
- The University of Texas Medical Branch, Galveston
- People needed
- 154
- Starts
- 2019-04-18
- Expected to finish
- 2020-02-28
- Last updated by the study team
- 2021-10-05
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 18-50 years of age.
- Women ≥ 24 weeks' viable gestation.
- To undergo cesarean delivery.
- Admission BMI ≥ 35.
You may not qualify if…
- Patient unwilling or unable to provide consent.
- No prenatal care or a non-resident patient who is unlikely to be followed-up after delivery.
- Immunosuppressed subjects: i.e., taking systemic immunosuppressant or steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV with CD4 <200, or other.
- Decision not to have skin closure (e.g. secondary wound closure, mesh closure).
- Current skin infection.
- Coagulopathy.
- High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, bowel or adnexal surgery).
- Known allergy to CHG.
- Incarcerated individuals.
- Chorioamnionitis.
- Subjects participating on other treatment trials or studies that would interfere with the current study's primary outcome.
Where it is running
- Ashley Salazar — Galveston, Texas, United States
Full record on ClinicalTrials.gov
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