Clinical trial · Interventional
Clinical Trial of New Elastomer for Maxillofacial Prosthetics
Multicenter Trial of CPE for Maxillofacial Prosthetics
NCT00123097CI-TRIAL-00026854completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Birth Injuries | — | UNRESOLVED | — |
| Facial Neoplasms | — | UNRESOLVED | — |
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Head Injuries, Penetrating | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chlorinated polyethylene elastomer | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chlorinated polyethylene elastomer first
- description
- Patient receives prosthetic made from CPE then the SOC, silicon.
- interventionNames
- Combination Product: Chlorinated polyethylene elastomer
- type
- ACTIVE_COMPARATOR
- label
- Silicon first
- description
- Patient receives prosthetic made from the SOC, silicon, followed by the CPE,Chlorinated polyethylene elastomer.
- interventionNames
- Combination Product: Chlorinated polyethylene elastomer
Primary outcomes (1)
- measure
- Non-inferiority of chlorinated polyethylene elastomer (CPE) material
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKiat-amnuay S, Jacob RF, Chambers MS, Anderson JD, Sheppard RA, Johnston DA, Haugh GS, Gettleman L. Clinical trial of chlorinated polyethylene for facial prosthetics. Int J Prosthodont. 2010 May-Jun;23(3):263-70. PMID 20552094