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| Sponsored by: |
West Virginia University |
| Information provided by: | West Virginia University |
| ClinicalTrials.gov Identifier: | NCT00654641 |
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.
| Condition | Intervention |
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Surgical Wound Dehiscence Wound Infection |
Procedure: Negative Pressure Wound Closure Procedure: Standard Wound Closure |
| MedlinePlus related topics: | Cesarean Section Obesity |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Prevention of Abdominal Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy |
| Estimated Enrollment: | 220 |
| Study Start Date: | September 2007 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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1: Experimental
Negative Pressure wound closure
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Procedure: Negative Pressure Wound Closure
Negative Pressure wound closure for 72 hours post-operatively
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2: Active Comparator
Standard Wound Closure
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Procedure: Standard Wound Closure
Suture closure of subcutaneous tissue and skin stapling and sterile bandage placement.
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Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Michael L Stitely, MD | 304-293-1566 | MStitely@hsc.wvu.edu |
| Contact: Jodi Rhodes, RN | 304-598-4878 | RhodesJ@rcbhsc.wvu.edu@ |
| United States, West Virginia | |||||
| West Virginia University | Recruiting | ||||
| Morgantown, West Virginia, United States, 26506 | |||||
| Contact: Michael L Stitely, MD 304-293-1566 MStitely@hsc.wvu.edu | |||||
| Principal Investigator: Michael L Stitely, MD | |||||
| Sub-Investigator: Roger C Toffle, MD | |||||
| Sub-Investigator: Shon P Rowan, MD | |||||
| Sub-Investigator: Kelley Gannon | |||||
| West Virginia University |
| Principal Investigator: | Michael L Stitely, MD | West Virginia University |
More Information
| Responsible Party: | West Virginia University ( Michael L. Stitely, MD ) |
| Study ID Numbers: | H-20292 |
| First Received: | April 2, 2008 |
| Last Updated: | August 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00654641 |
| Health Authority: | United States: Institutional Review Board |
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