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

NCT00654641 | Terminated Results

• 1 other identifier: H-20292
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

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.

Conditions

Surgical Wound Dehiscence; Wound Infection

Keywords

Surgical Wound Dehiscence; Wound Infection; Obesity; Cesarean Delivery; Wound Closure; Negative Pressure wound closure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Negative pressure wound closure

EXPERIMENTAL

Negative Pressure wound closure

Procedure: Negative pressure wound closure

Standard wound closure

ACTIVE COMPARATOR

Standard Wound Closure

Procedure: Standard wound closure

Interventions

Negative pressure wound closure PROCEDURE

Applying negative pressure to primary wound closure

Negative pressure wound closure

Standard wound closure PROCEDURE

Standard wound closure

Standard wound closure

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West Virginia University: lead
• CAMC Health System: collaborator

Study Sites (2)

CAMC Women and Children's Hospital

Charleston, West Virginia, 25304, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Surgical Wound Dehiscence; Wound Infection; Obesity

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Limitations and Caveats

Slow enrollment caused the closure of the trial prior to meeting enrollment target.

Results Point of Contact

• Title: Michael L. Stitely, MD
• Organization: West Viginia University

mstitely@hsc.wvu.edu

304-293-1566

Study Officials

• Michael L Stitely, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Associate Professor

Study Record Dates

• First Submitted: April 2, 2008
• First Posted: April 8, 2008
• Study Start: September 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: January 30, 2013
• Results First Posted: January 30, 2013

Record last verified: 2012-12

Locations

US (2)