Columbia, Missouri 65212


Purpose:

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 wound closure, and these wounds are prone to increased swelling and wound complications. The recent observation that IVAC decreases wound edema and increases oxygenation has led to their use in such cases. Used in conjunction, it is entirely possible that the negative pressure exerted by the IVAC can remove BMP-2 from surgical site and therefore decreases the effectiveness of BMP-2. We seek to determine if BMP-2 is present in effluent from the IVAC. If in this study the hypothesis is found to be wrong, and BMP-2 is found within the IVAC effluent, we are prepared to proceed with a follow-up study to quantify the BMP-2 removed by the IVAC.


Criteria:

Inclusion Criteria: - 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 Criteria: - 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


NCT ID:

NCT00829621


Primary Contact:

Principal Investigator
Brett D. Crist, MD
University of Missouri-Columbia

Brett D Crist, MD
Phone: 573-882-6562


Backup Contact:

N/A


Location Contact:

Columbia, Missouri 65212
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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