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

This study has been terminated.
(Poor enrollment. No apparent treatment effect.)
Sponsor:
Collaborator:
CAMC Health System
Information provided by (Responsible Party):
Michael Stitely, West Virginia University
ClinicalTrials.gov Identifier:
NCT00654641
First received: April 2, 2008
Last updated: December 18, 2012
Last verified: December 2012
History of Changes
Results First Received: February 3, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Surgical Wound Dehiscence
Wound Infection
Interventions: Procedure: Negative pressure wound closure
Procedure: Standard wound closure

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Negative Pressure Wound Closure Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound.
Standard Wound Closure Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples.

Participant Flow:   Overall Study
    Negative Pressure Wound Closure     Standard Wound Closure  
STARTED     28     26  
COMPLETED     26     23  
NOT COMPLETED     2     3  
Lost to Follow-up                 2                 3  



  Baseline Characteristics
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Reporting Groups
  Description
Negative Pressure Wound Closure Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound.
Standard Wound Closure Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples.
Total Total of all reporting groups

Baseline Measures
    Negative Pressure Wound Closure     Standard Wound Closure     Total  
Number of Participants  
[units: participants]
 		  28     26     54  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     28     26     54  
>=65 years     0     0     0  
Gender  
[units: participants]
 		     
Female     28     26     54  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     28     26     54  



  Outcome Measures

1.  Primary:   Total Number of Patients Experiencing a Wound Complication   [ Time Frame: 6 Weeks post-partum ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Slow enrollment caused the closure of the trial prior to meeting enrollment target.  


Results Point of Contact:  
Name/Title: Michael L. Stitely, MD
Organization: West Viginia University
phone: 304-293-1566
e-mail: mstitely@hsc.wvu.edu


No publications provided


Responsible Party: Michael Stitely, West Virginia University
ClinicalTrials.gov Identifier: NCT00654641     History of Changes
Other Study ID Numbers: H-20292
Study First Received: April 2, 2008
Results First Received: February 3, 2010
Last Updated: December 18, 2012
Health Authority: United States: Institutional Review Board