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

Wound Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00654641
• Other study ID #: H-20292
• Status: Terminated
• Phase: N/A
• First received: April 2, 2008
• Last updated: December 18, 2012
• Start date: September 2007
• Est. completion date: February 2010

Study information

• Verified date: December 2012
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Surgical Wound Dehiscence
• Wound Infection

Intervention

Procedure:
• Negative pressure wound closure
Applying negative pressure to primary wound closure
• Standard wound closure
Standard wound closure

Locations

Country	Name	City	State
United States	CAMC Women and Children's Hospital	Charleston	West Virginia
United States	West Virginia University	Morgantown	West Virginia

Sponsors (2)

Lead Sponsor	Collaborator
West Virginia University	CAMC Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Number of Patients Experiencing a Wound Complication	Superficial or deep space surgical site infection, or any type of wound disruption, including wound hematoma or seroma.	6 Weeks post-partum	No