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Loss of cGMP facility to manufacture product used in clinical trial.
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The purpose of this study is to compare the safety and effectiveness of performing oral reconstructive surgeries using either AlloDerm, a product commonly used for this purpose, or AlloDerm that has been overlaid with the subject's oral mucosal cells and developed into a type of graft that is called an ex vivo produced oral mucosal equivalent, EVPOME.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AlloDerm | Active Comparator | The subject will be treated with the standard of care, AlloDerm, to cover the defect in the mouth. |
|
| EVPOME | Experimental | An ex-vivo produced oral mucose equivalent (EVPOME) will be used to cover the defect in the top of the mouth. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AlloDerm | Biological |
| ||
| EVPOME |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Graft Contracture | During surgery, after preparation of the recipient bed, the recipient bed and the graft will be measured for the maximum distance between non-resorbable sutures placed at the margins of the graft. Post-surgical measurements of the graft site will be taken at visits 5, 6, 7, and 8 and compared to original graft size to assess percentage of graft contracture. | 2-24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Epithelialized Tissue | Degree of epithelialized mucosa will be assessed by biopsy taken at the geometric center of the graft at week 4 s/p grafting. The biopsy will be evaluated by routine histology for the presence of an intact and stratified keratinized epithelial layer and by immunohistochemistry (IHC) for microvessel vascular ingrowth into the dermis/dermal matrix (AlloDerm). | 4 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Graft Color | Graft color is correlated to vascular perfusion and thus can give us an indication of graft vascularity. Primarily we expect the color rendition to be similar to the surrounding tissue. Finger pressure will be applied in the center of the graft for 15 seconds and/or until tissue blanching. The pressure will then be released and the time for the tissue to return to its previous color will be timed. If the tissue returns to its previous color within 15 seconds, this will be recorded as positive graft vascularity. If not, then it will be recorded as negative graft vascularity. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Feinberg, DDS, MS, PhD | Faculty | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D008338 | Mandibular Injuries |
| ID | Term |
|---|---|
| D008446 | Maxillofacial Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| C440568 | Alloderm |
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| Laser Doppler Flowmetry (LDF) | LDF measurements will be used to assess graft blood flow (tissue perfusion of the grafts). The LDF measures will also be compared with the immunohistochemistry (IHC) results seen on the biopsy to determine the relationship between the flood flow and degree of microvessel infiltration into the dermis/dermal matrix (AlloDerm) based on the two measures. | Visit 1 and 2 and 4 weeks after surgery |
| 4 weeks after surgery |
| D009422 |
| Nervous System Diseases |
| D014947 | Wounds and Injuries |