Clinical Trial of New Elastomer for Maxillofacial Prosthetics

Completed · Phase 3

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

In brief

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.

Key facts

Study ID

NCT00123097

Run by

University of Louisville

People needed

42

Starts

2005-02-01

Expected to finish

2009-08-01

Last updated by the study team

2017-04-07

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• University of Louisville — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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