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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 75 mmHg suction | Active Comparator | IVAC suction 75 mmHg |
|
| 125 mmHg suction | Experimental | IVAC suction 125 mmHg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 75 mmHg suction | Other | Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brett D. Crist, MD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri | Columbia | Missouri | 65212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 75 mmHg | IVAC suction 75 mmHg 75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use. |
| FG001 | 125 mmHg | IVAC suction 125 mmHg 125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 75 mmHg | IVAC suction 75 mmHg 75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use. |
| BG001 | 125 mmHg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Presence of BMP-2 in Effluent Collected in IVAC Canister | Presence of BMP-2 in effluent collected in IVAC canister | Posted | Number | participants | 12-hours, 24-hours, 36-hours, and 48-hours after IVAC application |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 75 mmHg | IVAC suction 75 mmHg 75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| died secondary to chronic renal failure | Renal and urinary disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| delayed union | Musculoskeletal and connective tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brett Crist, MD | University of Missouri, Department of Orthopaedics | 573-882-6562 | cristb@health.missouri.edu |
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| ID | Term |
|---|---|
| D005596 | Fractures, Closed |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| 125 mmHg | Other | Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use. |
|
IVAC suction 125 mmHg
125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
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|
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| 1 |
| 8 |
| 1 |
| 8 |
| EG001 | 125 mmHg | IVAC suction 125 mmHg 125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use. | 1 | 12 | 0 | 12 |
| pulmonary embolis | Respiratory, thoracic and mediastinal disorders |
|
| nonunion | Musculoskeletal and connective tissue disorders |
|
| wound infection | Infections and infestations |
|
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