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Preventing Adverse Incisional Outcomes at Cesarean Multicenter Trial

NCT03009110 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1624

Last updated 2023-06-01

Study results available
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Summary

The Prophylactic Negative Pressure Wound Therapy in Obese Women at Cesarean Trial is a large pragmatic multi-center randomized clinical trial designed to evaluate the effectiveness, safety and cost-effectiveness of prophylactic negative pressure wound therapy (NPWT) - a closed, sealed system that applies negative pressure to the wound surface via a single-use, battery-powered, portable device - to decrease surgical site infections (SSIs) in obese women.

Conditions

  • Surgical Wound Infection
  • Cesarean Section

Interventions

DEVICE

Prophylactic NPWT

The Prevena NPWT system is a small, lightweight, portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary foam and adhesive dressing. It is supplied as a pump with a sterile dressing kit and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 13 to 20 cm and more. The pump maintains negative pressure of -125 mmHg to the wound surface. The device is placed after skin closure.

DEVICE

Standard Dressing

Standard wound dressing is routine postoperative wound dressing consisting of layers of gauze and adhesive tape.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • 3M

    collaborator INDUSTRY

  • Indiana University

    lead OTHER

Principal Investigators

  • Methodius G Tuuli, MD, MPH · Indiana University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-08
Primary Completion
2019-11-13
Completion
2019-11-13
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 NCT03009110 on ClinicalTrials.gov