Do Single Use Negative Pressure Dressings Reduce Wound Complications in Obese Women After Cesarean Delivery

NCT02799667 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2021-02-21

Study results available
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Summary

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.

Conditions

  • Obesity
  • Surgical Site Infections
  • Wound Complications
  • Complications; Cesarean Section

Interventions

DEVICE

Standard Dressing

Patients are randomized to the standard dressing at the time of fascial closure.

DEVICE

Negative Pressure Wound Therapy Dressing

Patients are randomized to the NPWT at the time of fascial closure.

Sponsors & Collaborators

  • Tufts Medical Center

    lead OTHER

Principal Investigators

  • Michael House, MD · Tufts Medical Center, physician

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2019-03-31
Completion
2019-03-31

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT02799667 on ClinicalTrials.gov