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

Not Applicable

Completed

• Conditions: Fractures, Closed
• Interventions: Other: 125 mmHg; Other: 75 mmHg suction

• Registration Number: NCT00829621
• Lead Sponsor: University of Missouri-Columbia

Brief 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).

Detailed Description

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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-01-26
• Study First Submitted QC: 2009-01-26
• Study First Posted: 2009-01-27
• Primary Completion: 2012-05
• Study Completion: 2013-12
• Results First Submitted: 2014-01-01
• Results First Submitted QC: 2014-01-01
• Results First Posted: 2014-02-21
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-02
• Last Update Posted: 2016-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
125 mmHg suction	125 mmHg	IVAC suction 125 mmHg
75 mmHg suction	75 mmHg suction	IVAC suction 75 mmHg

Primary Outcome Measures

Name	Time	Method
Presence of BMP-2 in Effluent Collected in IVAC Canister	12-hours, 24-hours, 36-hours, and 48-hours after IVAC application	Presence of BMP-2 in effluent collected in IVAC canister

Trial Locations

Locations (1)

University of Missouri; 🇺🇸 Columbia, Missouri, United States