EVPOME Versus AlloDerm in Subjects Reconstructed With Large Defect Mandibular Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01834339
Recruitment Status : Terminated (Loss of cGMP facility to manufacture product used in clinical trial.)
First Posted : April 17, 2013
Last Update Posted : November 22, 2017
Information provided by (Responsible Party):
Stephen E. Feinberg, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Mandibular Injuries Biological: AlloDerm Biological: EVPOME Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2015

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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).

  2. 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.

Other Outcome Measures:
  1. Graft Color [ Time Frame: 4 weeks after surgery ]
    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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01834339

United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
Stephen E. Feinberg
Principal Investigator: Stephen Feinberg, DDS, MS, PhD Faculty

Responsible Party: Stephen E. Feinberg, Professor & Associate Chair of Research, University of Michigan Identifier: NCT01834339     History of Changes
Other Study ID Numbers: HUM00069761
First Posted: April 17, 2013    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Stephen E. Feinberg, University of Michigan:

Additional relevant MeSH terms:
Mandibular Injuries
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries