Clinical Trial of New Elastomer for Maxillofacial Prosthetics

Study Overview
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Brief Summary
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The purpose of this study is to evaluate a new rubber material used to make prosthetic replacements of the face lost to cancer, trauma, or birth defects.

Detailed Description
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Maxillofacial prosthetics is a subspecialty of prosthodontics, providing the clinical rehabilitation treatment of patients who have lost parts of the face due to cancer, trauma, or birth defects. It is an orphan field that: treats few patients, making the subspecialty unprofitable for manufacturers to develop new materials; offers fundamental rehabilitation and improvement in the quality of life to patients who may have exhausted personal or third party funding; and provides a dental solution to an essentially medical problem. Silicone rubber materials have been used for facial rehabilitation for more than 4 decades with few improvements. There is a clear need for new, alternative, and more economic materials for extraoral maxillofacial prostheses. Research at Gulf South Research Institute in New Orleans by the Principal Investigator and others in the 1970s and 1980s developed an alternative low-cost thermoplastic industrial rubber material (chlorinated polyethylene, CPE) that met all toxicological (safety) and physical (effectiveness) requirements. A Phase 2 clinical trial at the time yielded equivocal results when compared to conventional but costly silicone rubber products. This research is a controlled, randomized, single-crossover, double-blinded investigator-initiated multicenter Phase 3 clinical trial treating 100 patients that evaluates: experimental thermoplastic CPE; and control silicone (Silastic Adhesive A/MDX4-4210) materials for non-inferiority of CPE based on functional and subjective characteristics, and on the quality of life. The clinical centers of the trial are at M.D. Anderson Cancer Center in Houston, Texas, and at the Toronto Sunnybrook Regional Cancer Centre in Toronto, Canada.

Official Title
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Multicenter Trial of CPE for Maxillofacial Prosthetics

Conditions
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Facial Neoplasms, Head and Neck Neoplasms, Head Injuries, Penetrating, Birth Injuries

Intervention / Treatment
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* Combination Product: Chlorinated polyethylene elastomer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Requires treatment for developmental or acquired extraoral facial defect Fully healed wound (6 months after surgery and/or radiation) Defect no larger than 9 x 12 cm (3.5 x 4.5 inches, the diameter of a giant bronze flask) Cognizant enough to answer questionnaires Agrees to wear the prosthesis at least 6 hours per day Agrees to use the prescribed adhesive (Epithane-3 - now called Daro Adhesive Extra Strength) and clean and store as instructed Plans to be able to return to the research institution for a 10 month period Able to manage prosthesis him/herself or with caregiver for a 10 month period Karnofsky score greater than or equal to 60 (www.hospicepatients.org/karnofsky.html) No framework or implant/magnet retention No multiple recurrences of tumor No hypersensitivity to adhesives or test materials No current systemic or topical facial steroid treatment Not legally blind Not expected to have further surgeries to defect, radiation therapy, or other cytoreductive therapy over the next 10 months No evidence of active skin condition/disease Not an infectious risk patient

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorinated polyethylene elastomer first<br>Patient receives prosthetic made from CPE then the SOC, silicon. | Combination Product: Chlorinated polyethylene elastomer<br>* Chlorinated polyethylene<br>* Other names: CPE;|
| Active Comparator: Silicon first<br>Patient receives prosthetic made from the SOC, silicon, followed by the CPE,Chlorinated polyethylene elastomer. | Combination Product: Chlorinated polyethylene elastomer<br>* Chlorinated polyethylene<br>* Other names: CPE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-inferiority of chlorinated polyethylene elastomer (CPE) material |  | 10 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Facial Neoplasms, Head and Neck Neoplasms, Head Injuries, Penetrating, Birth Injuries