Preventing Adverse Incisional Outcomes at Cesarean Multicenter Trial

Stopped early · Not applicable

Conditions studied: Surgical Wound Infection, Cesarean Section

In brief

The Prophylactic Negative Pressure Wound Therapy in Obese Women at Cesarean Trial is a large pragmatic multi-center randomized clinical trial designed to evaluate the effectiveness, safety and cost-effectiveness of prophylactic negative pressure wound therapy (NPWT) - a closed, sealed system that applies negative pressure to the wound surface via a single-use, battery-powered, portable device - to decrease surgical site infections (SSIs) in obese women.

Key facts

Study ID

NCT03009110

Run by

Indiana University

People needed

1624

Starts

2017-02-08

Expected to finish

2019-11-13

Last updated by the study team

2023-06-01

Who can join

Age: 16 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Gestational age ≥23weeks
• BMI≥30 Pre-pregnancy or BMI at first prenatal visit
• Planned or unplanned cesarean delivery

You may not qualify if…

• Non-availability for postoperative follow-up
• Contraindication to NPWT applicable to women undergoing cesarean: Pre-existing infection around incision site, Bleeding disorder, Therapeutic anticoagulation, Irradiated skin, Allergy to any component of the dressing (e.g. silver, acrylic, silicone, adhesive tape)

Where it is running

• University of Alabama Medical Center — Birmingham, Alabama, United States
• Eskenazi Hopsital — Indianapolis, Indiana, United States
• Methodist Hospital — Indianapolis, Indiana, United States
• Ochsner Baptist Medical Center — New Orleans, Louisiana, United States
• Barnes-Jewish Hospital — St Louis, Missouri, United States
• Mercy Hosptial St Louis — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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