EVPOME Versus AlloDerm in Subjects Reconstructed With Large Defect Mandibular Resection

NCT01834339 — Phase 2, Terminated, 1 participants, Stephen E. Feinberg

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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

Registry	NCT01834339
Status	Terminated - Loss of cGMP facility to manufacture product used in clinical trial.
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	1 (Actual)
Sponsor	Stephen E. Feinberg (Other)
Conditions	Mandibular Injuries
Interventions	AlloDerm, EVPOME (Biological)
Dates	start 2013-09-01, primary completion 2014-11-01, completion 2015-12-01, first posted 2013-04-17, last updated 2017-11-22
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
AlloDerm	Active comparator	Biological: AlloDerm	The subject will be treated with the standard of care, AlloDerm, to cover the defect in the mouth.
EVPOME	Experimental	Biological: EVPOME	An ex-vivo produced oral mucose equivalent (EVPOME) will be used to cover the defect in the top of the mouth.

AlloDerm (Biological)
EVPOME (Biological)

+Outcome measures

Primary outcomes

Percent Graft Contracture [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 outcomes

Degree of Epithelialized Tissue [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) [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 outcomes

Graft Color [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.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
University of Michigan	Ann Arbor, Michigan	United States

+Investigators

Stephen Feinberg, DDS, MS, PhD, Principal investigator, Faculty