EVPOME Versus AlloDerm in Subjects Reconstructed With Large Defect Mandibular Resection

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

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.

Study Overview

• Status: Terminated
• Conditions: Mandibular Injuries
• Intervention / Treatment: Biological: AlloDerm; Biological: EVPOME

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Graft Contracture	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.	2-24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of Epithelialized Tissue	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).	4 weeks after surgery
Laser Doppler Flowmetry (LDF)	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.	Visit 1 and 2 and 4 weeks after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft Color	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.	4 weeks after surgery

Collaborators and Investigators

• Sponsor: Stephen E. Feinberg
• Investigators: Principal Investigator: Stephen Feinberg, DDS, MS, PhD, Faculty

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: April 12, 2013
• First Submitted That Met QC Criteria: April 16, 2013
• First Posted (Estimate): April 17, 2013

Study Record Updates

• Last Update Posted (Actual): November 22, 2017
• Last Update Submitted That Met QC Criteria: November 20, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: vestibuloplasty
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Maxillofacial Injuries; Facial Injuries; Mandibular Injuries
• Other Study ID Numbers: HUM00069761

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No