Status:
COMPLETED
Incisional Vacuum Assisted Closure (IVAC) Device and Its Effect on Implanted Bone Morphogenic Protein (BMP-2)
Lead Sponsor:
University of Missouri-Columbia
Collaborating Sponsors:
Medtronic
Conditions:
Fractures, Closed
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
People who have been scheduled for surgery using Bone Morphogenic Protein (called BMP-2) and an incisional vacuum assisted closure device (called IVAC) will be asked to join this study. The purpose o...
Detailed Description
It is hypothesized that the negative pressure associated with an IVAC is not sufficient to remove BMP-2 from a surgical wound. BMP-2 is commonly used in open tibia fractures at the time of definitive...
Eligibility Criteria
Inclusion
- Subject is 18 years or older
- Subject has tibia fracture requiring treatment with BMP-2
- Subject to have an Incisional Vacuum Closure (IVAC) Device, placed on the skin directly over the BMP-2 implantation site
- Subject/guardian able to provide informed consent
Exclusion
- Subject is less than 18 years old
- Subject has a wound at fracture/surgical site that cannot be closed
- Subject/guardian unable to provide informed consent
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00829621
Start Date
December 1 2008
End Date
December 1 2013
Last Update
November 7 2016
Active Locations (1)
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1
University of Missouri
Columbia, Missouri, United States, 65212