NCT00123097

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

April 7, 2017

Status Verified

April 1, 2017

Enrollment Period

4.5 years

First QC Date

July 21, 2005

Last Update Submit

April 5, 2017

Conditions

Facial NeoplasmsHead and Neck NeoplasmsHead Injuries, PenetratingBirth Injuries

Keywords

Facial NeoplasmsHead and Neck NeoplasmsHead Injuries, PenetratingBirth Injuries

Outcome Measures

Primary Outcomes (1)

  • Non-inferiority of chlorinated polyethylene elastomer (CPE) material

    10 month

Study Arms (2)

Chlorinated polyethylene elastomer first

EXPERIMENTAL

Patient receives prosthetic made from CPE then the SOC, silicon.

Combination Product: Chlorinated polyethylene elastomer

Silicon first

ACTIVE COMPARATOR

Patient receives prosthetic made from the SOC, silicon, followed by the CPE,Chlorinated polyethylene elastomer.

Combination Product: Chlorinated polyethylene elastomer

Interventions

Chlorinated polyethylene elastomerCOMBINATION_PRODUCT

Chlorinated polyethylene

Also known as: CPE
Chlorinated polyethylene elastomer firstSilicon first

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40292-0001, United States

Location

Related Publications (1)

  • Kiat-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: 20552094DERIVED

MeSH Terms

Conditions

Facial NeoplasmsHead and Neck NeoplasmsHead Injuries, PenetratingBirth Injuries

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesWounds and InjuriesWounds, PenetratingInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Sudarat Kiat-amnuay, DDS MS

    University of Texas Dental Branch

    STUDY CHAIR

  • Mark S Chambers, DMD MS

    MD Anderson Cancer Center, Dept. of Head & Neck Surgery

    STUDY CHAIR

  • James D Anderson, DDS MScD

    Toronto Sunnybrook Regional Cancer Centre

    PRINCIPAL INVESTIGATOR

  • Lawrence Gettleman, DMD, MSD

    University of Louisville, School of Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DEVICE FEASIBILITY
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Gratis

Study Record Dates

First Submitted

July 21, 2005

First Posted

July 22, 2005

Study Start

February 1, 2005

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

April 7, 2017

Record last verified: 2017-04

Locations

US(1)