Clinical Trial: EVPOME Versus AlloDerm in Subjects Reconstructed With Large Defect Mandibular Resection

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Randomized, Parallel-Group (Autogenous EVPOME Versus AlloDerm Without Incorporation of Keratinocytes) Study in Subjects Reconstructed With Large Defect Mandibular Resection in Need of Vestibuloplast

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 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.

Detailed Summary:
Sponsor: Stephen E. Feinberg

Current Primary Outcome: Percent Graft Contracture [ Time Frame: 2-24 weeks ]

During surgery, after preparation of the recipient bed, the recipient bed and the graft will be measured for the maximum distance between non-resorbable sutures placed at the margins of the graft. Post-surgical measurements of the graft site will be taken at visits 5, 6, 7, and 8 and compared to original graft size to assess percentage of graft contracture.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Degree of Epithelialized Tissue [ Time Frame: 4 weeks after surgery ]
    Degree of epithelialized mucosa will be assessed by biopsy taken at the geometric center of the graft at week 4 s/p grafting. The biopsy will be evaluated by routine histology for the presence of an intact and stratified keratinized epithelial layer and by immunohistochemistry (IHC) for microvessel vascular ingrowth into the dermis/dermal matrix (AlloDerm).
  • Laser Doppler Flowmetry (LDF) [ Time Frame: Visit 1 and 2 and 4 weeks after surgery ]
    LDF measurements will be used to assess graft blood flow (tissue perfusion of the grafts). The LDF measures will also be compared with the immunohistochemistry (IHC) results seen on the biopsy to determine the relationship between the flood flow and degree of microvessel infiltration into the dermis/dermal matrix (AlloDerm) based on the two measures.


Original Secondary Outcome: Same as current

Information By: University of Michigan

Dates:
Date Received: April 12, 2013
Date Started: September 2013
Date Completion:
Last Updated: November 16, 2016
Last Verified: November 2016