Incisional Vacuum Assisted Closure (IVAC) Device and Its Effect on Implanted Bone Morphogenic Protein (BMP-2)
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/1/2014 |
| Start Date: | December 2008 |
| End Date: | December 2010 |
| Contact: | Brett D Crist, MD |
| Phone: | 573-882-6562 |
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.
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.
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
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