EVPOME Versus AlloDerm in Subjects Reconstructed With Large Defect Mandibular Resection
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 your own oral mucosal cells and developed into a type of graft that is called an ex vivo produced oral mucosal equivalent, EVPOME.
Subjects in Need of Dental Rehabilitation Who Have Undergone a Mandibular Resection and Have Had a Microvascular Free Fibular Graft Placed.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, Parallel-Group (Autogenous EVPOME Versus AlloDerm Without Incorporation of Keratinocytes) Study in Subjects Reconstructed With Large Defect Mandibular Resection in Need of Vestibuloplasty for Dental Rehabilitation|
- Percent Graft Contracture [ Time Frame: 2-24 weeks ] [ Designated as safety issue: No ]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.
- Degree of Epithelialized Tissue [ Time Frame: 4 weeks after surgery ] [ Designated as safety issue: No ]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).
- Laser Doppler Flowmetry (LDF) [ Time Frame: Visit 1 and 2 and 4 weeks after surgery ] [ Designated as safety issue: No ]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.
- Graft Color [ Time Frame: 4 weeks after surgery ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Active Comparator: AlloDerm
The subject will be treated with the standard of care, AlloDerm, to cover the defect in the mouth.
An ex-vivo produced oral mucose equivalent (EVPOME) will be used to cover the defect in the top of the mouth.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01834339
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Stephen E Feinberg, DDS, MS, PhD 734-763-5963 firstname.lastname@example.org|
|Principal Investigator: Stephen E Feinberg, DDS, MS, PhD|