Status:
COMPLETED
Clinical Trial of New Elastomer for Maxillofacial Prosthetics
Lead Sponsor:
University of Louisville
Collaborating Sponsors:
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Facial Neoplasms
Head and Neck Neoplasms
Eligibility:
All Genders
21+ years
Phase:
PHASE3
Brief 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.
Detailed 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 i...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00123097
Start Date
February 1 2005
End Date
August 1 2009
Last Update
April 7 2017
Active Locations (1)
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1
University of Louisville
Louisville, Kentucky, United States, 40292-0001