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

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Brett Crist, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00829621
First received: January 26, 2009
Last updated: January 1, 2014
Last verified: January 2014

January 26, 2009
January 1, 2014
December 2008
May 2012   (final data collection date for primary outcome measure)
Presence of BMP-2 in Effluent Collected in IVAC Canister [ Time Frame: 12-hours, 24-hours, 36-hours, and 48-hours after IVAC application ] [ Designated as safety issue: No ]
Presence of BMP-2 in effluent collected in IVAC canister
Presence of BMP-2 in effluent collected in IVAC canister [ Time Frame: 12-hours, 24-hours, 36-hours, and 48-hours after IVAC application ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00829621 on ClinicalTrials.gov Archive Site
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Incisional Vacuum Assisted Closure (IVAC) Device and Its Effect on Implanted Bone Morphogenic Protein (BMP-2)
Incisional Vacuum Assisted Closure (IVAC) Device and Its Effect on Implanted Bone Morphogenic Protein (BMP-2)

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.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Fractures, Closed
  • BMP-2
  • Incisional Vacuum Assisted Closure (IVAC)
  • Other: 75 mmHg suction
    Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use.
  • Other: 125 mmHg
    Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use.
  • Active Comparator: 75 mmHg
    IVAC suction 75 mmHg
    Intervention: Other: 75 mmHg suction
  • Experimental: 125 mmHg
    IVAC suction 125 mmHg
    Intervention: Other: 125 mmHg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
December 2013
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00829621
IRB 1097637
No
Brett Crist, University of Missouri-Columbia
University of Missouri-Columbia
Medtronic
Principal Investigator: Brett D. Crist, MD University of Missouri-Columbia
University of Missouri-Columbia
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP