Incisional Vacuum Assisted Closure (IVAC) Device and Its Effect on Implanted Bone Morphogenic Protein (BMP-2)

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Brett Crist, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00829621
First received: January 26, 2009
Last updated: January 1, 2014
Last verified: January 2014
Results First Received: January 1, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Fractures, Closed
BMP-2
Incisional Vacuum Assisted Closure (IVAC)
Interventions: Other: 75 mmHg suction
Other: 125 mmHg

  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
No text entered.

Reporting Groups
  Description
75 mmHg

IVAC suction 75 mmHg

75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use.

125 mmHg

IVAC suction 125 mmHg

125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use.


Participant Flow:   Overall Study
    75 mmHg     125 mmHg  
STARTED     8     12  
COMPLETED     4     8  
NOT COMPLETED     4     4  
Death                 1                 0  
Lost to Follow-up                 3                 4  



  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
75 mmHg

IVAC suction 75 mmHg

75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use.

125 mmHg

IVAC suction 125 mmHg

125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use.

Total Total of all reporting groups

Baseline Measures
    75 mmHg     125 mmHg     Total  
Number of Participants  
[units: participants]
  8     12     20  
Age  
[units: years]
Mean ± Standard Deviation
  45  ± 17.5     42.1  ± 16.6     43  ± 17  
Gender  
[units: participants]
     
Female     3     3     6  
Male     5     9     14  



  Outcome Measures

1.  Primary:   Presence of BMP-2 in Effluent Collected in IVAC Canister   [ Time Frame: 12-hours, 24-hours, 36-hours, and 48-hours after IVAC application ]


  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
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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.


Results Point of Contact:  
Name/Title: Brett Crist, MD
Organization: University of Missouri, Department of Orthopaedics
phone: 573-882-6562
e-mail: cristb@health.missouri.edu


No publications provided


Responsible Party: Brett Crist, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00829621     History of Changes
Other Study ID Numbers: IRB 1097637
Study First Received: January 26, 2009
Results First Received: January 1, 2014
Last Updated: January 1, 2014
Health Authority: United States: Institutional Review Board