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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
West Virginia University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

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

First Posted
April 2, 2008
Last Updated
December 18, 2012
Sponsor
West Virginia University
Collaborators
CAMC Health System
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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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