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| Sponsors and Collaborators: |
University of Missouri-Columbia Medtronic |
|---|---|
| Information provided by: | University of Missouri-Columbia |
| ClinicalTrials.gov Identifier: | NCT00829621 |
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.
| Condition | Intervention |
|---|---|
|
Fractures, Closed BMP-2 Incisional Vacuum Assisted Closure (IVAC) |
Other: 75 mmHg suction Other: 125 mmHg |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
| Official Title: | Incisional Vacuum Assisted Closure (IVAC) Device and Its Effect on Implanted Bone Morphogenic Protein (BMP-2) |
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
75 mmHg: Active Comparator
IVAC suction 75 mmHg
|
Other: 75 mmHg suction
Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use.
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|
125 mmHg: Experimental
IVAC suction 125 mmHg
|
Other: 125 mmHg
Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Linda K Anderson, BSN | 573-884-0854 |
| United States, Missouri | |
| University of Missouri | Recruiting |
| Columbia, Missouri, United States, 65212 | |
| Principal Investigator: Brett D. Crist, MD | |
| Sub-Investigator: Gregory J. Della Rocca, MD, PhD | |
| Sub-Investigator: Jason A. Lowe, MD | |
| Sub-Investigator: Santaram Vallurupalli, MD | |
| Principal Investigator: | Brett D. Crist, MD | University of Missouri-Columbia |
More Information
| Responsible Party: | University of Missouri ( Brett D. Crist, MD ) |
| Study ID Numbers: | IRB 1097637 |
| Study First Received: | January 26, 2009 |
| Last Updated: | January 26, 2009 |
| ClinicalTrials.gov Identifier: | NCT00829621 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Fractures, Bone Wounds and Injuries Disorders of Environmental Origin Fractures, Closed |
|
Fractures, Bone Wounds and Injuries Disorders of Environmental Origin Fractures, Closed |
