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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:
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
  Purpose

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.


Condition Intervention
Fractures, Closed
BMP-2
Incisional Vacuum Assisted Closure (IVAC)
Other: 75 mmHg suction
Other: 125 mmHg

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Incisional Vacuum Assisted Closure (IVAC) Device and Its Effect on Implanted Bone Morphogenic Protein (BMP-2)

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • 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


Enrollment: 23
Study Start Date: December 2008
Study Completion Date: December 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 75 mmHg
IVAC suction 75 mmHg
Other: 75 mmHg suction
Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use.
Experimental: 125 mmHg
IVAC suction 125 mmHg
Other: 125 mmHg
Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829621

Locations
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Medtronic
Investigators
Principal Investigator: Brett D. Crist, MD University of Missouri-Columbia
  More Information

No publications provided

Responsible Party: Brett Crist, Assistant Professor, Co-Director of Trauma Services, Co-Director Trauma Fellowship, Department of Orthopaedic Surgery, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00829621     History of Changes
Other Study ID Numbers: IRB 1097637
Study First Received: January 26, 2009
Results First Received: January 1, 2014
Last Updated: January 1, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fractures, Closed
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014