EVPOME Versus AlloDerm in Subjects Reconstructed With Large Defect Mandibular Resection

Stopped early · Phase 2

Conditions studied: Mandibular Injuries

In brief

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.

Key facts

Study ID

NCT01834339

Run by

Stephen E. Feinberg

People needed

1

Starts

2013-09-01

Expected to finish

2015-12-01

Last updated by the study team

2017-11-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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