Phase 4
Completed N=154
Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery
Cesarean Section Complications · Wound Breakdown · Chronic Wounds · Satisfaction
Source: ClinicalTrials.gov NCT03887299 ↗
Enrolled (actual)
154
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Satisfaction and QoL Questionnaire — 49; 52 Score
◆ Published Evidence
Emerging
4citations · ~1 / year
Antimicrobial Dressing versus Standard Dressing in Obese Women Undergoing Cesarean Delivery: A Randomized Controlled Trial.
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).
Linked Publications
-
Antimicrobial Dressing versus Standard Dressing in Obese Women Undergoing Cesarean Delivery: A Randomized Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Satisfaction and QoL Questionnaire |
49; 52 | — |
| SECONDARY Number of Participants With Composite Wound Complication |
5; 9 | — |
| SECONDARY Number of Participants With Wound Breakdown |
1; 0 | — |
| SECONDARY Number of Participants That Resulted in Maternal Death |
0; 0 | — |
| SECONDARY Number of Participants With Puerperal Fever |
0; 1 | — |
| SECONDARY Provider Satisfaction |
17; 21 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03887299) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.