Incisional Vacuum Assisted Closure (IVAC) Device and Its Effect on Implanted Bone Morphogenic Protein (BMP-2)
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 of this study is to see if using the IVAC device removes BMP-2 from the wound. BMP-2 is a protein used by the body to increase bone healing, decrease the need for additional surgery, and reduce infection rates.
The IVAC is a device that involves a foam dressing secured with an adhesive drape to make an airtight seal over a surgical incision. Tubing runs from the foam dressing to a device that uses gentle suction to drain fluid out (like a vacuum). The IVAC stays on for 48-72 hours depending on amount of drainage. The IVAC by itself helps reduce wound swelling and complications (such as infection).
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Incisional Vacuum Assisted Closure (IVAC) Device and Its Effect on Implanted Bone Morphogenic Protein (BMP-2)|
- Presence of BMP-2 in Effluent Collected in IVAC Canister [ Time Frame: 12-hours, 24-hours, 36-hours, and 48-hours after IVAC application ] [ Designated as safety issue: No ]Presence of BMP-2 in effluent collected in IVAC canister
|Study Start Date:||December 2008|
|Study Completion Date:||December 2013|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Active Comparator: 75 mmHg suction
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.
Experimental: 125 mmHg suction
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00829621
|United States, Missouri|
|University of Missouri|
|Columbia, Missouri, United States, 65212|
|Principal Investigator:||Brett D. Crist, MD||University of Missouri-Columbia|