Overview

This trial is active, not recruiting.

Conditions facial neoplasms, head and neck neoplasms, head injuries, penetrating, birth injuries
Treatment chlorinated polyethylene elastomer
Phase phase 3
Sponsor University of Louisville
Collaborator National Institute of Dental and Craniofacial Research (NIDCR)
Start date February 2005
End date July 2012
Trial size 100 participants
Trial identifier NCT00123097, 5U01 DE-014543, NCT00408486, NIDCR-14543, U01DE014543

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment

Primary Outcomes

Measure
Non-inferiority of chlorinated polyethylene elastomer (CPE) material
time frame: 10 month

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title Multicenter Trial of CPE for Maxillofacial Prosthetics
Principal investigator James D Anderson, DDS MScD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by University of Louisville.