Clinical Trial of New Elastomer for Maxillofacial Prosthetics
Facial Neoplasms, Head and Neck Neoplasms, Head Injuries, Penetrating
About this trial
This is an interventional device feasibility trial for Facial Neoplasms focused on measuring Facial Neoplasms, Head and Neck Neoplasms, Head Injuries, Penetrating, Birth Injuries
Eligibility Criteria
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
Sites / Locations
- University of Louisville
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Chlorinated polyethylene elastomer first
Silicon first
Patient receives prosthetic made from CPE then the SOC, silicon.
Patient receives prosthetic made from the SOC, silicon, followed by the CPE,Chlorinated polyethylene elastomer.