Prevention of Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy - Full Text View

Sponsors and Collaborators:	West Virginia University CAMC Health System
Information provided by:	West Virginia University
ClinicalTrials.gov Identifier:	NCT00654641

Purpose

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.

Condition	Intervention
Surgical Wound Dehiscence Wound Infection	Procedure: Negative Pressure Wound Closure Procedure: Standard Wound Closure

MedlinePlus related topics: Cesarean Section Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Prevention of Abdominal Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy

Further study details as provided by West Virginia University:

Primary Outcome Measures:

Total Wound Complications [ Time Frame: 7-14 days and at 6 weeks post-op ] [ Designated as safety issue: No ]

Estimated Enrollment:	220
Study Start Date:	September 2007
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Negative Pressure wound closure	Procedure: Negative Pressure Wound Closure Negative Pressure wound closure for 72 hours post-operatively
2: Active Comparator Standard Wound Closure	Procedure: Standard Wound Closure Suture closure of subcutaneous tissue and skin stapling and sterile bandage placement.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Undergoing Cesarean delivery.
Patient at least 18 years of age.
Weight greater than 199 pounds.
Depth of subcutaneous tissue (measured from fascia to epidermis) of greater than or equal to 5 centimeters.

Exclusion Criteria:

Weight less or equal to 199 pounds or less than 5 cm of subcutaneous tissue present.
Inability to give proper informed consent.
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).
Patient less than 18 years of age.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654641

Contacts

Contact: Michael L Stitely, MD	304-293-1566	MStitely@hsc.wvu.edu
Contact: Jodi Rhodes, RN	304-598-4878	RhodesJ@rcbhsc.wvu.edu@

Locations

United States, West Virginia
West Virginia University	Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Michael L Stitely, MD 304-293-1566 MStitely@hsc.wvu.edu
Principal Investigator: Michael L Stitely, MD
Sub-Investigator: Roger C Toffle, MD
Sub-Investigator: Shon P Rowan, MD
Sub-Investigator: Kelley Gannon
CAMC Women and Children's Hospital	Recruiting
Charleston, West Virginia, United States, 25304
Contact: Luis Bracero, MD 304-388-1599
Principal Investigator: Luis Bracero, MD

Sponsors and Collaborators

West Virginia University

CAMC Health System

Investigators

Principal Investigator:

Michael L Stitely, MD

West Virginia University

More Information

Responsible Party:	West Virginia University ( Michael L. Stitely, MD )
Study ID Numbers:	H-20292
Study First Received:	April 2, 2008
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00654641
Health Authority:	United States: Institutional Review Board

Keywords provided by West Virginia University:

Surgical Wound Dehiscence
Wound Infection
Obesity

Cesarean Delivery
Wound Closure
Negative Pressure wound closure

Study placed in the following topic categories:

Surgical Wound Dehiscence
Obesity
Postoperative Complications

Wounds and Injuries
Disorders of Environmental Origin
Wound Infection

Additional relevant MeSH terms:

Pathologic Processes
Infection

ClinicalTrials.gov processed this record on January 16, 2009