View Clinical Trial (Medical Research Study)
Prevention of Abdominal Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy
| City: |
|
Morgantown |
| State: |
|
West Virginia |
| Zip Code: |
|
26506 |
| Conditions: |
|
Surgical Wound Dehiscence - Wound Infection |
| 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.
|
| Study Summary: |
|
|
| 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.
|
| NCT ID: |
|
NCT00654641 |
| Primary Contact: |
|
Principal Investigator
Michael L Stitely, MD
West Virginia University
Michael L Stitely, MD
Phone: 304-293-1566
Email: MStitely@hsc.wvu.edu
|
| Backup Contact: |
|
Email: RhodesJ@rcbhsc.wvu.edu@
Jodi Rhodes, RN
Phone: 304-598-4878
|
| Location Contact: |
|
Morgantown, West Virginia 26506
United States
Michael L Stitely, MD
Phone: 304-293-1566
Email: MStitely@hsc.wvu.edu
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 20, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|