CompletedNot Applicable

Negative Pressure Wound Therapy to Prevent Wound Complications Following Cesarean Section in High Risk Patients

United States154 participantsStarted 2015-06

Plain-language 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).

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Wound Complication

Timeframe: post operative day 1-42

Trial details

NCT IDNCT03082664

SponsorUniversity of Arizona

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-03

Results submitted2022-04-15

View on ClinicalTrials.gov More High Risk Pregnancy trials