Use of Negative Pressure Wound Therapy in Morbidly Obese Women After Cesarean Delivery

Stopped early · Not applicable

Conditions studied: Obesity, Morbid, Wound Infection, Wound Complication

In brief

Obese women are more likely have a cesarean delivery and develop subsequent wound complications than normal weight women. Negative pressure wound therapy (NPWT) has been shown to improve surgical wound healing, but this device has not been adequately studied in cesarean deliveries. The aim of our study is to determine the efficacy of NPWT in morbidly obese women after cesarean delivery. Investigators will be randomizing women with a BMI \> 40 kg/m2 in a 1:1 ratio to either NPWT (the PREVENA Incision management therapy system Pre 1001 Us) or standard dressing after their cesarean delivery at MedStar Washington Hospital Center. The NPWT will be left in place for a minimum of four days but not to exceed seven days. The standard dressing is typically removed on postoperative day one or two. The primary outcome is a wound complication defined as the formation of a wound infection, seroma, hematoma, separation, or dehiscence from delivery to 4 weeks postpartum. Investigators will also administer a patient satisfaction survey regarding their wound healing experience.

Key facts

Study ID
NCT03269968
Run by
Medstar Health Research Institute
People needed
25
Starts
2017-10-03
Expected to finish
2019-06-30
Last updated by the study team
2020-10-19

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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