Prevention of Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy
Status
Conditions
Treatments
Details and patient eligibility
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
54 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal