Negative Pressure Wound Therapy in Cesarean Section

Completed · Not applicable · Has a placebo group

Conditions studied: Postoperative Wound Complications

In brief

The investigators propose a prospective, randomized trial evaluating the use of negative pressure wound therapy (NPWT) with high risk obstetrical patients. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators aim to look at all wound complications such as infection and disruption and will be using Prevena incision management system for our NPWT device .

Key facts

Study ID: NCT02289157
Run by: University of Texas Southwestern Medical Center
People needed: 441
Starts: 2015-01-27
Expected to finish: 2016-10-21
Last updated by the study team: 2018-07-02

Who can join

Age: 10 and older, up to 64. Sex: female. Healthy volunteers: accepted.

You may qualify if…

Pregnant women with BMI > 40 undergoing a cesarean delivery at Parkland Health and Hospital System.

You may not qualify if…

Any patient not meeting inclusion criteria will be deemed ineligible.
All HIV positive patients will be excluded due to the increased risk of infectious complications in these patients.
Although patients on anticoagulants can use NPWT, they will be excluded as there may be an increased risk of bleeding in these patients.
according to the wound therapy manufacturer's instructions patients with:
fragile skin
allergy to silver or acrylic adhesives
a malignancy in the wound bed or margins of the wound bed
non-enteric and unexplored fistulas
necrotic tissue with eschar present
exposed arteries, veins, nerves or organs, anastomotic sites, or surgical suction are not candidates for usage of the device.

Where it is running

Parkland Memorial Hospital — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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