EVPOME Versus AlloDerm in Subjects Reconstructed With Large Defect Mandibular Resection

Stephen E. Feinberg

Status and phase

Terminated

Phase 2

Conditions

Mandibular Injuries

Treatments

Biological: AlloDerm

Biological: EVPOME

Study type

Interventional

Funder types

Other

Identifiers

NCT01834339

HUM00069761

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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