Fractures, Closed
Conditions
Keywords
BMP-2, Incisional Vacuum Assisted Closure (IVAC)
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.
Interventions
OTHER75 mmHg suction
Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use.
OTHER125 mmHg
Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use.
Sponsors
Medtronic
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of BMP-2 in Effluent Collected in IVAC Canister | 12-hours, 24-hours, 36-hours, and 48-hours after IVAC application | Presence of BMP-2 in effluent collected in IVAC canister |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| 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. | 12 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 3 | 4 |
Baseline characteristics
| Characteristic | 75 mmHg | 125 mmHg | Total |
|---|---|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 17.5 | 42.1 years STANDARD_DEVIATION 16.6 | 43 years STANDARD_DEVIATION 17 |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 5 Participants | 9 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 8 | 0 / 12 |
| serious Total, serious adverse events | 1 / 8 | 1 / 12 |
Outcome results
Primary
Presence of BMP-2 in Effluent Collected in IVAC Canister
Presence of BMP-2 in effluent collected in IVAC canister
Time frame: 12-hours, 24-hours, 36-hours, and 48-hours after IVAC application
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 75 mmHg | Presence of BMP-2 in Effluent Collected in IVAC Canister | 6 participants |
| 125 mmHg | Presence of BMP-2 in Effluent Collected in IVAC Canister | 11 participants |
p-value: =0.36t-test, 1 sided