Incisional Vacuum Assisted Closure (IVAC) Device and Its Effect on Implanted Bone Morphogenic Protein (BMP-2)
Primary Purpose
Fractures, Closed
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
75 mmHg suction
125 mmHg
Sponsored by
About this trial
This is an interventional treatment trial for Fractures, Closed focused on measuring BMP-2, Incisional Vacuum Assisted Closure (IVAC)
Eligibility 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
Sites / Locations
- University of Missouri
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
75 mmHg suction
125 mmHg suction
Arm Description
IVAC suction 75 mmHg
IVAC suction 125 mmHg
Outcomes
Primary Outcome Measures
Presence of BMP-2 in Effluent Collected in IVAC Canister
Presence of BMP-2 in effluent collected in IVAC canister
Secondary Outcome Measures
Full Information
NCT ID
NCT00829621
First Posted
January 26, 2009
Last Updated
October 2, 2016
Sponsor
University of Missouri-Columbia
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT00829621
Brief Title
Incisional Vacuum Assisted Closure (IVAC) Device and Its Effect on Implanted Bone Morphogenic Protein (BMP-2)
Official Title
Incisional Vacuum Assisted Closure (IVAC) Device and Its Effect on Implanted Bone Morphogenic Protein (BMP-2)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
Collaborators
Medtronic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures, Closed
Keywords
BMP-2, Incisional Vacuum Assisted Closure (IVAC)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
75 mmHg suction
Arm Type
Active Comparator
Arm Description
IVAC suction 75 mmHg
Arm Title
125 mmHg suction
Arm Type
Experimental
Arm Description
IVAC suction 125 mmHg
Intervention Type
Other
Intervention Name(s)
75 mmHg suction
Intervention Description
Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use.
Intervention Type
Other
Intervention Name(s)
125 mmHg
Intervention Description
Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use.
Primary Outcome Measure Information:
Title
Presence of BMP-2 in Effluent Collected in IVAC Canister
Description
Presence of BMP-2 in effluent collected in IVAC canister
Time Frame
12-hours, 24-hours, 36-hours, and 48-hours after IVAC application
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brett D. Crist, MD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Incisional Vacuum Assisted Closure (IVAC) Device and Its Effect on Implanted Bone Morphogenic Protein (BMP-2)
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