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Vacuum Assisted Closure as a Treatment for Open Fractures (VAC-OF)

This study has been completed.
Sponsor:
Collaborator:
KCI USA, Inc.
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00582361
First received: December 20, 2007
Last updated: August 5, 2013
Last verified: May 2012
Results First Received: July 27, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Orthopaedic Traumatic Open Fractures
Interventions: Procedure: Standard Wound Dressing
Device: VAC

  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
Patients admitted through the emergency department that met the criteria for the study were approached.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Standard Dressing Group (1, A) Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
Vacuum Assisted Closure Group (2, B) Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.

Participant Flow:   Overall Study
    Standard Dressing Group (1, A)   Vacuum Assisted Closure Group (2, B)
STARTED   25   38 
COMPLETED   25   38 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Standard Dressing Group (1, A) Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
Vacuum Assisted Closure Group (2, B) Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
Total Total of all reporting groups

Baseline Measures
   Standard Dressing Group (1, A)   Vacuum Assisted Closure Group (2, B)   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   38   63 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   23   35   58 
>=65 years   2   3   5 
Age 
[Units: Years]
Mean (Standard Deviation)
 44  (16)   38  (15)   41  (15) 
Gender 
[Units: Participants]
     
Female   10   10   20 
Male   15   28   43 
Region of Enrollment 
[Units: Participants]
     
United States   25   38   63 


  Outcome Measures
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1.  Primary:   Healing of Orthopaedic Trauma Open Fractures   [ Time Frame: from surgery to wound closure ]

2.  Primary:   Infections   [ Time Frame: Up to 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
None Noted.


  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.


Results Point of Contact:  
Name/Title: Research Nurse Coordinator
Organization: UAB
phone: 205-996-6781
e-mail: Talyor.vlack@ortho.uab.edu


Publications:

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00582361     History of Changes
Other Study ID Numbers: F010316004
Study First Received: December 20, 2007
Results First Received: July 27, 2011
Last Updated: August 5, 2013
Health Authority: United States: Institutional Review Board