NCT00654641

Prevention of Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy

Prevention of Abdominal Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: West Virginia University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Surgical Wound Dehiscence
• Wound Infection

Interventions

Type	Name	Description
PROCEDURE	Negative pressure wound closure	Applying negative pressure to primary wound closure
PROCEDURE	Standard wound closure	Standard wound closure

Timeline

• Start date: 2007-09-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2008-04-08
• Last updated: 2013-01-30
• Results posted: 2013-01-30

Locations

2 sites across 1 country: United States