EVPOME Versus AlloDerm in Subjects Reconstructed With Large Defect Mandibular Resection

NCT01834339 | Terminated Phase 2 DMC

• 1 other identifier: HUM00069761
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Mandibular Injuries

Keywords

vestibuloplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Degree of Epithelialized Tissue

  4 weeks after surgery

• Laser Doppler Flowmetry (LDF)

  Visit 1 and 2 and 4 weeks after surgery

Other Outcomes (1)

• Graft Color

  4 weeks after surgery

Study Arms (2)

AlloDerm

ACTIVE COMPARATOR

The subject will be treated with the standard of care, AlloDerm, to cover the defect in the mouth.

Biological: AlloDerm

EVPOME

EXPERIMENTAL

An ex-vivo produced oral mucose equivalent (EVPOME) will be used to cover the defect in the top of the mouth.

Biological: EVPOME

Interventions

AlloDerm BIOLOGICAL

AlloDerm

EVPOME BIOLOGICAL

EVPOME

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stephen E. Feinberg: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Mandibular Injuries

Interventions

Alloderm

Condition Hierarchy (Ancestors)

Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Study Officials

• Stephen Feinberg, DDS, MS, PhD

  Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor & Associate Chair of Research

Study Record Dates

• First Submitted: April 12, 2013
• First Posted: April 17, 2013
• Study Start: September 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2015
• Last Updated: November 22, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)