EVPOME Versus AlloDerm in Subjects Reconstructed With Large Defect

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial 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.

See also
Status	Clinical Trial	Phase
Completed	`NCT03054012` - Accuracy and Outcome of Computer-assisted Surgery for Bony Micro-vascular Reconstruction in the Head and Neck Region
Recruiting	`NCT03678467` - Evaluation of EpiBone-CMF for Mandibular Ramus Reconstruction	Phase 1/Phase 2
Completed	`NCT00628849` - Champy Versus AO for Mandible Fractures	N/A

NCT number	NCT01834339
Study type	Interventional
Source	University of Michigan
Contact
Status	Terminated
Phase	Phase 2
Start date	September 2013
Completion date	December 2015

EVPOME Versus AlloDerm in Subjects Reconstructed With Large Defect Mandibular Resection

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms