Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery (NCT03887299) | Clinical Trial Compass
CompletedPhase 4
Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery
United States154 participantsStarted 2019-04-18
Plain-language summary
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).
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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Inclusion Criteria:
* 18-50 years of age.
* Women ≥ 24 weeks' viable gestation.
* To undergo cesarean delivery.
* Admission BMI ≥ 35.
Exclusion Criteria:
* 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.
What they're measuring
1
Satisfaction and QoL Questionnaire
Timeframe: Postpartum wound care visit (up to 10days postpartum)
Trial details
NCT IDNCT03887299
SponsorThe University of Texas Medical Branch, Galveston