Prevention of Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy

December 18, 2012 updated by: Michael Stitely, West Virginia University

Prevention of Abdominal Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy

Wound complications after Cesarean section (C-section) are common in obese women. Approximately 25% of obese women having a C-section will have a wound complication. This research study is designed to assess whether applying a source of vacuum (suction) to the wound can reduce the risk of wound complications. The investigators plan to enroll 220 women into the study.

Women will be randomly selected to receive standard stitching and stapling of the incision (cut on the abdomen) or closure with stitches, staples and wound suction. Subjects will be seen for follow-up visits in 7-14 days and again at 4-6 weeks after surgery. The number of wound complications in each group will be compared. If the wound suction technique is successful in preventing wound complications, this may substantially reduce pain and suffering in a large number of women undergoing C-section for delivery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • CAMC Women and Children's Hospital
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Undergoing Cesarean delivery.
  2. Patient at least 18 years of age.
  3. Weight greater than 199 pounds.
  4. Depth of subcutaneous tissue (measured from fascia to epidermis) of greater than or equal to 4 centimeters.

Exclusion Criteria:

  1. Weight less or equal to 199 pounds or less than 4 cm of subcutaneous tissue present.
  2. Inability to give proper informed consent.
  3. Inability to adhere to follow-up provisions of the study (return for 2 post-operative visits at 7-14 days post-op and between 4-6 weeks post-op).
  4. Patient less than 18 years of age.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Negative pressure wound closure
Negative Pressure wound closure
Procedure: Negative pressure wound closure
Applying negative pressure to primary wound closure
Active Comparator: Standard wound closure
Standard Wound Closure
Procedure: Standard wound closure
Standard wound closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Number of Patients Experiencing a Wound Complication
Time Frame: 6 Weeks post-partum
Superficial or deep space surgical site infection, or any type of wound disruption, including wound hematoma or seroma.
6 Weeks post-partum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West Virginia University

Collaborators

CAMC Health System

Investigators

  • Principal Investigator: Michael L Stitely, MD, West Virginia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

April 2, 2008

First Submitted That Met QC Criteria

April 7, 2008

First Posted (Estimate)

April 8, 2008

Study Record Updates

Last Update Posted (Estimate)

January 30, 2013

Last Update Submitted That Met QC Criteria

December 18, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-20292

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Wound Infection

Clinical Trials on Negative pressure wound closure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe