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EVPOME Versus AlloDerm in Subjects Reconstructed With Large Defect Mandibular Resection

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Stephen E. Feinberg, University of Michigan
ClinicalTrials.gov Identifier:
NCT01834339
First received: April 12, 2013
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

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 your own oral mucosal cells and developed into a type of graft that is called an ex vivo produced oral mucosal equivalent, EVPOME.


Condition Intervention Phase
Subjects in Need of Dental Rehabilitation Who Have Undergone a Mandibular Resection and Have Had a Microvascular Free Fibular Graft Placed.
Biological: AlloDerm
Biological: EVPOME
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Vestibuloplasty for Dental Rehabilitation

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Percent Graft Contracture [ Time Frame: 2-24 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Degree of Epithelialized Tissue [ Time Frame: 4 weeks after surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Graft Color [ Time Frame: 4 weeks after surgery ] [ Designated as safety issue: No ]
    Graft color is correlated to vascular perfusion and thus can give us an indication of graft vascularity. Primarily we expect the color rendition to be similar to the surrounding tissue. Finger pressure will be applied in the center of the graft for 15 seconds and/or until tissue blanching. The pressure will then be released and the time for the tissue to return to its previous color will be timed. If the tissue returns to its previous color within 15 seconds, this will be recorded as positive graft vascularity. If not, then it will be recorded as negative graft vascularity.


Estimated Enrollment: 20
Study Start Date: September 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AlloDerm
The subject will be treated with the standard of care, AlloDerm, to cover the defect in the mouth.
Biological: AlloDerm
Experimental: EVPOME
An ex-vivo produced oral mucose equivalent (EVPOME) will be used to cover the defect in the top of the mouth.
Biological: EVPOME

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01834339

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Stephen E Feinberg, DDS, MS, PhD    734-763-5963    sefein@umich.edu   
Principal Investigator: Stephen E Feinberg, DDS, MS, PhD         
Sponsors and Collaborators
Stephen E. Feinberg
  More Information

No publications provided

Responsible Party: Stephen E. Feinberg, Professor & Associate Chair of Research, University of Michigan
ClinicalTrials.gov Identifier: NCT01834339     History of Changes
Other Study ID Numbers: HUM00069761
Study First Received: April 12, 2013
Last Updated: September 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Michigan:
vestibuloplasty

ClinicalTrials.gov processed this record on November 20, 2014