Prevention of Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy
Stopped early · Not applicable
Conditions studied: Surgical Wound Dehiscence, Wound Infection
In brief
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.
Key facts
- Study ID
- NCT00654641
- Run by
- West Virginia University
- People needed
- 54
- Starts
- 2007-09-01
- Expected to finish
- 2010-02-01
- Last updated by the study team
- 2013-01-30
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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 4 centimeters.
You may not qualify if…
- Weight less or equal to 199 pounds or less than 4 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.
Where it is running
- CAMC Women and Children's Hospital — Charleston, West Virginia, United States
- West Virginia University — Morgantown, West Virginia, United States
Full record on ClinicalTrials.gov
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