Status:
COMPLETED
Negative Pressure Wound Therapy in Cesarean Section
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
KCI USA, Inc
Conditions:
Postoperative Wound Complications
Eligibility:
FEMALE
10-64 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
This will be a prospective, randomized, controlled trial of pregnant women who present for prenatal care at Parkland Health and Hospital System. The participants will be limited to women undergoing a ...
Eligibility Criteria
Inclusion
- Pregnant women with BMI \> 40 undergoing a cesarean delivery at Parkland Health and Hospital System.
Exclusion
- 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.
Key Trial Info
Start Date :
January 27 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2016
Estimated Enrollment :
441 Patients enrolled
Trial Details
Trial ID
NCT02289157
Start Date
January 27 2015
End Date
October 21 2016
Last Update
July 2 2018
Active Locations (1)
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1
Parkland Memorial Hospital
Dallas, Texas, United States, 75235