EVPOME Versus AlloDerm in Subjects Reconstructed With Large Defect Mandibular Resection

Phase 2

Terminated

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
AlloDerm	AlloDerm	The subject will be treated with the standard of care, AlloDerm, to cover the defect in the mouth.
EVPOME	EVPOME	An ex-vivo produced oral mucose equivalent (EVPOME) will be used to cover the defect in the top of the mouth.

Primary Outcome Measures

Name	Time	Method
Percent Graft Contracture	2-24 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Degree of Epithelialized Tissue	4 weeks after surgery	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)	Visit 1 and 2 and 4 weeks after surgery	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.