N/A
Completed N=154
Negative Pressure Wound Therapy to Prevent Wound Complications Following Cesarean Section in High Risk Patients
High Risk Pregnancy · Cesarean Wound Disruption With Postnatal Complication
Source: ClinicalTrials.gov NCT03082664 ↗
Enrolled (actual)
154
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcomePrimary: Wound Complication — 13; 14 Participants
Summary
This is a randomized controlled trial. Patients with a condition that increases their risk of a wound complication will be approached for inclusion in the trial. Each participant agreeing to study inclusion will be randomized to either suture alone or to closure of their skin incision with suture and then with prophylactic placement of a wound vac (PICO).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wound Complication |
13; 14 | — |
Eligibility Criteria
Inclusion Criteria
- Maternal Age 18 or above
- Cesarean delivery
- Maternal condition which increases the risk of wound complication. These conditions include: Obesity (BMI >30), diabetes, HIV/AIDS, chorioamnionitis, rheumatologic disease, history of wound complication, anticoagulant therapy.
- Patient able to read and speak English or Spanish.
Exclusion Criteria
- Minors (<18 years of age)
- Non-cesarean wound (ie tubal ligation wound)
- No high risk maternal condition
- Patient unable to read and speak English or Spanish.
- Prisoners
Data sourced from ClinicalTrials.gov (NCT03082664). 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.