Incisional Vacuum Assisted Closure (IVAC) Device and Its Effect on Implanted Bone Morphogenic Protein (BMP-2)

Completed · Not applicable

Conditions studied: Fractures, Closed

In brief

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).

Key facts

Study ID

NCT00829621

Run by

University of Missouri-Columbia

People needed

20

Starts

2008-12-01

Expected to finish

2013-12-01

Last updated by the study team

2016-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Missouri — Columbia, Missouri, United States

Full record on ClinicalTrials.gov

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