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

Not Applicable

Terminated

• Conditions: Surgical Wound Dehiscence; Wound Infection
• Interventions: Procedure: Negative pressure wound closure; Procedure: Standard wound closure

• Registration Number: NCT00654641
• Lead Sponsor: West Virginia University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-04-02
• Study First Submitted QC: 2008-04-07
• Study First Posted: 2008-04-08
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Results First Submitted: 2010-02-03
• Status Verified: 2012-12
• Results First Submitted QC: 2012-12-18
• Last Update Submitted: 2012-12-18
• Results First Posted: 2013-01-30
• Last Update Posted: 2013-01-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Negative pressure wound closure	Negative pressure wound closure	Negative Pressure wound closure
Standard wound closure	Standard wound closure	Standard Wound Closure

Primary Outcome Measures

Name	Time	Method
Total Number of Patients Experiencing a Wound Complication	6 Weeks post-partum	Superficial or deep space surgical site infection, or any type of wound disruption, including wound hematoma or seroma.

Trial Locations

Locations (2)

CAMC Women and Children's Hospital; 🇺🇸 Charleston, West Virginia, United States

West Virginia University; 🇺🇸 Morgantown, West Virginia, United States