Status:
TERMINATED
EVPOME Versus AlloDerm in Subjects Reconstructed With Large Defect Mandibular Resection
Lead Sponsor:
Stephen E. Feinberg
Conditions:
Mandibular Injuries
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01834339
Start Date
September 1 2013
End Date
December 1 2015
Last Update
November 22 2017
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109