TerminatedPhase 2

EVPOME Versus AlloDerm in Subjects Reconstructed With Large Defect Mandibular Resection

Stopped: Loss of cGMP facility to manufacture product used in clinical trial.

United States1 participantsStarted 2013-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percent Graft Contracture

Timeframe: 2-24 weeks

Trial details

NCT IDNCT01834339

SponsorStephen E. Feinberg

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-11