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

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ClinicalTrials.gov Identifier: NCT00654641
Recruitment Status : Terminated (Poor enrollment. No apparent treatment effect.)
First Posted : April 8, 2008
Results First Posted : January 30, 2013
Last Update Posted : January 30, 2013
Sponsor:
Collaborator:
CAMC Health System
Information provided by (Responsible Party):
Michael Stitely, West Virginia University

Brief Summary:

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 or disease Intervention/treatment Phase
Surgical Wound Dehiscence Wound Infection Procedure: Negative pressure wound closure Procedure: Standard wound closure Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Abdominal Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy
Study Start Date : September 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Michael Stitely, Adjunct Associate Professor, West Virginia University
ClinicalTrials.gov Identifier: NCT00654641     History of Changes
Other Study ID Numbers: H-20292
First Posted: April 8, 2008    Key Record Dates
Results First Posted: January 30, 2013
Last Update Posted: January 30, 2013
Last Verified: December 2012

Keywords provided by Michael Stitely, West Virginia University:
Surgical Wound Dehiscence
Wound Infection
Obesity
Cesarean Delivery
Wound Closure
Negative Pressure wound closure

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