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

This study has been terminated.
(Poor enrollment. No apparent treatment effect.)
Sponsor:
Collaborator:
CAMC Health System
Information provided by (Responsible Party):
Michael Stitely, West Virginia University
ClinicalTrials.gov Identifier:
NCT00654641
First received: April 2, 2008
Last updated: December 18, 2012
Last verified: December 2012
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Abdominal Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by West Virginia University:

Primary Outcome Measures:
  • Total Number of Patients Experiencing a Wound Complication [ Time Frame: 6 Weeks post-partum ] [ Designated as safety issue: No ]
    Superficial or deep space surgical site infection, or any type of wound disruption, including wound hematoma or seroma.


Enrollment: 54
Study Start Date: September 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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

Locations
United States, West Virginia
CAMC Women and Children's Hospital
Charleston, West Virginia, United States, 25304
West Virginia University
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
West Virginia University
CAMC Health System
Investigators
Principal Investigator: Michael L Stitely, MD West Virginia University
  More Information

No publications provided

Responsible Party: Michael Stitely, Adjunct Associate Professor, West Virginia University
ClinicalTrials.gov Identifier: NCT00654641     History of Changes
Other Study ID Numbers: H-20292
Study First Received: April 2, 2008
Results First Received: February 3, 2010
Last Updated: December 18, 2012
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

Additional relevant MeSH terms:
Surgical Wound Dehiscence
Wound Infection
Postoperative Complications
 Pathologic Processes
Infection
Wounds and Injuries

ClinicalTrials.gov processed this record on May 19, 2013