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

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. Identifier: NCT00829621
Recruitment Status : Completed
First Posted : January 27, 2009
Results First Posted : February 21, 2014
Last Update Posted : November 7, 2016
Information provided by (Responsible Party):
Brett Crist, University of Missouri-Columbia

Brief Summary:

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).

Condition or disease Intervention/treatment Phase
Fractures, Closed Other: 75 mmHg suction Other: 125 mmHg Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Incisional Vacuum Assisted Closure (IVAC) Device and Its Effect on Implanted Bone Morphogenic Protein (BMP-2)
Study Start Date : December 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : December 2013

Arm Intervention/treatment
Active Comparator: 75 mmHg suction
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 suction
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.

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00829621

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

Responsible Party: Brett Crist, Assistant Professor, Co-Director of Trauma Services, Co-Director Trauma Fellowship, Department of Orthopaedic Surgery, University of Missouri-Columbia Identifier: NCT00829621     History of Changes
Other Study ID Numbers: IRB 1097637
First Posted: January 27, 2009    Key Record Dates
Results First Posted: February 21, 2014
Last Update Posted: November 7, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Brett Crist, University of Missouri-Columbia:
Incisional Vacuum Assisted Closure (IVAC)

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