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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fractures, Closed

Intervention / Treatment
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* Other: 75 mmHg suction
* Other: 125 mmHg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 75 mmHg suction<br>IVAC suction 75 mmHg | Other: 75 mmHg suction<br>* Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use.<br>|
| Experimental: 125 mmHg suction<br>IVAC suction 125 mmHg | Other: 125 mmHg<br>* Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of BMP-2 in Effluent Collected in IVAC Canister | Presence of BMP-2 in effluent collected in IVAC canister | 12-hours, 24-hours, 36-hours, and 48-hours after IVAC application | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMP-2, Incisional Vacuum Assisted Closure (IVAC)