EVPOME Versus AlloDerm in Subjects Reconstructed With Large Defect Mandibular Resection

Mandibular Injuries Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01834339
• Other study ID #: HUM00069761
• Status: Terminated
• Phase: Phase 2
• First received: April 12, 2013
• Last updated: November 20, 2017
• Start date: September 2013
• Est. completion date: December 2015

Study information

• Verified date: November 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mandibular Injuries

Intervention

Biological:
• AlloDerm

• EVPOME

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Stephen E. Feinberg

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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