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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00829621
Other study ID # IRB 1097637
Secondary ID
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


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
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