Prophylactic Negative Pressure Wound Therapy in Obese Women at Cesarean: a Multicenter Randomized Trial
Status: Terminated
Location: See all (6) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 16
Healthy Volunteers: t
View:
• Gestational age ≥23weeks
• BMI≥30 Pre-pregnancy or BMI at first prenatal visit
• Planned or unplanned cesarean delivery
Locations
United States
Alabama
University of Alabama Medical Center
Birmingham
Indiana
Eskenazi Hopsital
Indianapolis
Methodist Hospital
Indianapolis
Louisiana
Ochsner Baptist Medical Center
New Orleans
Missouri
Barnes-Jewish Hospital
Saint Louis
Mercy Hosptial St Louis
Saint Louis
Time Frame
Start Date: 2017-02-08
Completion Date: 2019-11-13
Participants
Target number of participants: 1624
Treatments
Experimental: Prophylactic NPWT
Women assigned to prophylactic NPWT will have the Prevena device applied and secured with fixation adhesion strips. The device will be monitored while the patient is in the hospital to confirm that it is functioning well. The device will be removed prior to discharge, typically on postoperative day 4, but longer for up to 7 days for patients who remain hospitalized.
Active_comparator: Standard Dressing
Women assigned to standard care will receive routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing will be removed after 24 - 48 hours.
Sponsors
Collaborators: 3M, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Leads: Indiana University