EVPOME Versus AlloDerm in Subjects Reconstructed With Large Defect Mandibular Resection

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Mandibular Injuries

Intervention / Treatment
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* Biological: AlloDerm
* Biological: EVPOME


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be an adult over 18 years of age Have a free fibular graft placed more than six months ago that has been used for restoration of mandibular continuity. Be in need of surgery to increase the vestibular fold of the grafted mandible for placement of a dental prosthesis to restore function Exclusion Criteria: Any liver, kidney, heart, blood, metabolic or systemic disease which may make execution of the protocol of interpretation of the results difficult A history of syphilis, HIV, Hepatitis B or Hepatitis C Pregnancy or planning to become pregnant Known or suspected allergy to bovine (cow) protein Receiving radiation Currently smoking or using tobacco products Talking medication that can result in gingival enlargement (Cyclosporine, Dilantin, calcium channel blockers) Allergy to any of the following antibiotics Gentamycin, Cefoxitin, Lincomycin, Polymyxin B, Vancomycin, cephalosporins, or clindamycin Allergy to Polysorbate 20

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AlloDerm<br>The subject will be treated with the standard of care, AlloDerm, to cover the defect in the mouth. | Biological: AlloDerm<br> <br> |
| Experimental: EVPOME<br>An ex-vivo produced oral mucose equivalent (EVPOME) will be used to cover the defect in the top of the mouth. | Biological: EVPOME<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vestibuloplasty