Prevention of Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy
Primary Purpose
Surgical Wound Dehiscence, Wound Infection
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Negative pressure wound closure
Standard wound closure
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Wound Dehiscence focused on measuring Surgical Wound Dehiscence, Wound Infection, Obesity, Cesarean Delivery, Wound Closure, Negative Pressure wound closure
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- CAMC Women and Children's Hospital
- West Virginia University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Negative pressure wound closure
Standard wound closure
Arm Description
Negative Pressure wound closure
Standard Wound Closure
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00654641
First Posted
April 2, 2008
Last Updated
December 18, 2012
Sponsor
West Virginia University
Collaborators
CAMC Health System
1. Study Identification
Unique Protocol Identification Number
NCT00654641
Brief Title
Prevention of Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy
Official Title
Prevention of Abdominal Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment. No apparent treatment effect.
Study Start Date
September 2007 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia University
Collaborators
CAMC Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Dehiscence, Wound Infection
Keywords
Surgical Wound Dehiscence, Wound Infection, Obesity, Cesarean Delivery, Wound Closure, Negative Pressure wound closure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Negative pressure wound closure
Arm Type
Experimental
Arm Description
Negative Pressure wound closure
Arm Title
Standard wound closure
Arm Type
Active Comparator
Arm Description
Standard Wound Closure
Intervention Type
Procedure
Intervention Name(s)
Negative pressure wound closure
Intervention Description
Applying negative pressure to primary wound closure
Intervention Type
Procedure
Intervention Name(s)
Standard wound closure
Intervention Description
Standard wound closure
Primary Outcome Measure Information:
Title
Total Number of Patients Experiencing a Wound Complication
Description
Superficial or deep space surgical site infection, or any type of wound disruption, including wound hematoma or seroma.
Time Frame
6 Weeks post-partum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael L Stitely, MD
Organizational Affiliation
West Virginia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CAMC Women and Children's Hospital
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Prevention of Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy
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