Prevention of Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy
Sponsored by West Virginia University
About this trial
Last updated 12 years ago
Study ID
H-20292
Status
Terminated
Type
Interventional
Phase
N/A
Placebo
No
Accepting
18+ Years
Female
Not accepting
Healthy Volunteers
Trial Timing
Ended 15 years ago
What is this trial about?
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.
What are the participation requirements?
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.