Head and Neck Neoplasms Clinical Trial
Official title:
Multicenter Trial of CPE for Maxillofacial Prosthetics
Verified date | April 2017 |
Source | University of Louisville |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 42 |
Est. completion date | August 2009 |
Est. primary completion date | August 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Louisville | Louisville, | Kentucky |
Lead Sponsor | Collaborator |
---|---|
University of Louisville | National Institute of Dental and Craniofacial Research (NIDCR) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Non-inferiority of chlorinated polyethylene elastomer (CPE) material | 10 month |
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