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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00829621
First Posted: January 27, 2009
Last Update Posted: November 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic
Information provided by (Responsible Party):
Brett Crist, University of Missouri-Columbia
January 26, 2009
January 27, 2009
January 1, 2014
February 21, 2014
November 7, 2016
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 ]
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 ]
Complete list of historical versions of study NCT00829621 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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)

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).

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Fractures, Closed
  • 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 suction
    IVAC suction 75 mmHg
    Intervention: Other: 75 mmHg suction
  • Experimental: 125 mmHg suction
    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
20
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00829621
IRB 1097637
No
Not Provided
Plan to Share IPD: 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
October 2016

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