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

NCT03269968 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-10-19

Study results available
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Summary

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.

Conditions

  • Obesity, Morbid
  • Wound Infection
  • Wound Complication

Interventions

DEVICE

Negative pressure wound therapy (PREVENA Incision Management Therapy System)

After cesarean delivery, women in the intervention group will receive PREVENA Incision Management Therapy System.

DEVICE

Standard dressing

After cesarean delivery, women in the intervention group will receive standard dressing.

Sponsors & Collaborators

  • Amenity Health, Inc.

    collaborator INDUSTRY

  • Medstar Health Research Institute

    lead OTHER

Principal Investigators

  • Rachael T Overcash, MD, MPH · Medstar Health Research Institute

  • Iqbal N Iqbal, MD · Medstar Health Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-03
Primary Completion
2019-06-30
Completion
2019-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03269968 on ClinicalTrials.gov