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

Fractures, Closed Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00829621
• Other study ID #: IRB 1097637
• Status: Completed
• Phase: N/A
• First received: January 26, 2009
• Last updated: January 1, 2014
• Start date: December 2008
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• BMP-2
• Fractures, Closed
• Incisional Vacuum Assisted Closure (IVAC)

Intervention

Other:
• 75 mmHg suction
Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use.
• 125 mmHg
Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use.

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri-Columbia	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of BMP-2 in Effluent Collected in IVAC Canister	Presence of BMP-2 in effluent collected in IVAC canister	12-hours, 24-hours, 36-hours, and 48-hours after IVAC application	No