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Randomized Controlled Trial: Do Single Use Negative Pressure Dressings Reduce Wound Complications in Women With a BMI >40 kg/m2 Undergoing Cesarean Delivery at a Tertiary Medical Center?
The investigators aim to show that single use negative pressure dressings can decrease the rate of wound complications in obese women (BMI \> 40 kg/m2) undergoing cesarean delivery at a tertiary medical center by randomizing women to receive either a single use negative pressure dressing or the standard dressing after cesarean delivery.
Subjects admitted to L+D for obstetric or medical indications at a tertiary medical center with a BMI \> 40 kg/m2 will be asked to participate in a study on post surgical dressings and wound outcomes if they undergo cesarean delivery. Subjects will be randomized to either study arm at the time of fascial closure during cesarean delivery. Post operative care will not be altered. Incisions will be evaluated prior to hospital discharge. Subjects will present for a wound evaluation 2 weeks post operatively, and receive phone calls to assess outcomes at both 2 and 6 weeks post operatively.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
Yes
Tufts Medical Center
Boston, Massachusetts, United States
Start Date
May 1, 2016
Primary Completion Date
March 31, 2019
Completion Date
March 31, 2019
Last Updated
February 21, 2021
110
ACTUAL participants
Standard Dressing
DEVICE
Negative Pressure Wound Therapy Dressing
DEVICE
Lead Sponsor
Tufts Medical Center
NCT01143454
NCT07472881
Data Source & Attribution
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