Incisional Vacuum Assisted Closure (IVAC) Device and Its Effect on Implanted Bone Morphogenic Protein (BMP-2)
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Missouri | Columbia | Missouri | United States | 65212 |
Sponsors and Collaborators
- University of Missouri-Columbia
- Medtronic
Investigators
- Principal Investigator: Brett D. Crist, MD, University of Missouri-Columbia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB 1097637
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | 75 mmHg | 125 mmHg |
|---|---|---|
| Arm/Group Description | 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. | IVAC suction 125 mmHg 125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use. |
| Period Title: Overall Study | ||
| STARTED | 8 | 12 |
| COMPLETED | 4 | 8 |
| NOT COMPLETED | 4 | 4 |
Baseline Characteristics
| Arm/Group Title | 75 mmHg | 125 mmHg | Total |
|---|---|---|---|
| Arm/Group Description | 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. | IVAC suction 125 mmHg 125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use. | Total of all reporting groups |
| Overall Participants | 8 | 12 | 20 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
45
(17.5)
|
42.1
(16.6)
|
43
(17)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
3
37.5%
|
3
25%
|
6
30%
|
| Male |
5
62.5%
|
9
75%
|
14
70%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 75 mmHg | 125 mmHg |
|---|---|---|
| Arm/Group Description | 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. | IVAC suction 125 mmHg 125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use. |
| Measure Participants | 8 | 12 |
| Number [participants] |
6
75%
|
11
91.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 75 mmHg, 125 mmHg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | =0.36 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | 75 mmHg | 125 mmHg | ||
| Arm/Group Description | 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. | IVAC suction 125 mmHg 125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use. | ||
All Cause Mortality |
||||
| 75 mmHg | 125 mmHg | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| 75 mmHg | 125 mmHg | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/8 (12.5%) | 1/12 (8.3%) | ||
| Infections and infestations | ||||
| wound infection | 1/8 (12.5%) | 1/12 (8.3%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| nonunion | 0/8 (0%) | 1/12 (8.3%) | ||
| Renal and urinary disorders | ||||
| died secondary to chronic renal failure | 1/8 (12.5%) | 0/12 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| pulmonary embolis | 0/8 (0%) | 1/12 (8.3%) | ||
Other (Not Including Serious) Adverse Events |
||||
| 75 mmHg | 125 mmHg | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/8 (12.5%) | 0/12 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| delayed union | 1/8 (12.5%) | 0/12 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Brett Crist, MD |
|---|---|
| Organization | University of Missouri, Department of Orthopaedics |
| Phone | 573-882-6562 |
| cristb@health.missouri.edu |
- IRB 1097637