N/A N=20 Randomized Treatment

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

Fractures, Closed

Bottom Line

View on ClinicalTrials.gov: NCT00829621 ↗

Enrolled (actual)

Serious AEs

10.0%

Results posted

Feb 2014

Primary outcome: Primary: Presence of BMP-2 in Effluent Collected in IVAC Canister — 6; 11 participants — p==0.36

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 75 mmHg suction (Other); 125 mmHg (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Missouri-Columbia
Primary completion: May 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Presence of BMP-2 in Effluent Collected in IVAC Canister	6; 11	=0.36

Summary

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).

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00829621). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.