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Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients

NCT02309944 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2020-07-27

Study results available
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Summary

The purpose of the study is to test whether the use of a new wound closure technique can decrease the rates of wound complications in obese cancer patients.

Conditions

  • Postoperative Complications
  • Obesity
  • Gynecologic Neoplasms

Interventions

PROCEDURE

Standard Wound Closure

The standard surgical closure consists of closure of the fascia with a looped polydioxanone (PDS) suture in a running fashion either in with the use of a mass closure technique or a Smead Jones closure at the discretion of the operating surgeon, closure of the subcutaneous space if \>2 cm deep, followed by staple or suture closure of the skin.

DEVICE

Prevena™ Incision Management System

At the close of surgery, the Prevena™ Incision Management System will be placed over the closed incision. It will be removed on post-operative day 2 or 3 as clinically indicated and prior to the patient's discharge from the hospital.

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Deanna G. Teoh, M.D. · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT02309944 on ClinicalTrials.gov