Hypertrophic Scarring After Facial Burn

This study has been completed.
Sponsor:
Collaborator:
Total Contact
Information provided by (Responsible Party):
Helens Christians, Legacy Health System
ClinicalTrials.gov Identifier:
NCT00242970
First received: October 20, 2005
Last updated: March 31, 2015
Last verified: March 2015
  Purpose

Subjects with a burn to the face and/or neck will be enrolled into the study and a Three-Dimensional scanner used to see if it can objectively measure scar color and volume and measure the effect of scar on motion of the face and neck.


Condition Intervention Phase
Burn
Device: 3-Dimensional Color Scanning
Phase 2

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Hypertrophic Scarring After Facial Burn: A Pilot, Observational Study of Static and Dynamic Measurements of Facial Scars With the 3-D Scanner Through the Scar Maturation Process

Resource links provided by NLM:


Further study details as provided by Legacy Health System:

Primary Outcome Measures:
  • Scar maturation [ Time Frame: 5.5 years ] [ Designated as safety issue: No ]
    Can a 3-D scanner measure static and dynamic changes


Enrollment: 15
Study Start Date: October 2005
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: 3-Dimensional Color Scanning
    Color imaging of the face and neck.
    Other Name: Cyberware 3030 RGB Color Scanner
Detailed Description:

Subjects will have 11 clinic visits over a 2-year period. An initial scan of the subject's head and neck will be made. Ten reproducible landmarks on the face and neck will be determined. The subject will return for follow up scans at Day 14, Day 28 and Month 2,6,9,12,18 and 24.

  Eligibility

Ages Eligible for Study:   4 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Study population includes patients with burn injuries to their face and or neck.

Criteria

Inclusion Criteria:

  • Face and/or Neck Burn
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00242970

Locations
United States, Oregon
Legacy Emanuel Hospital and Health Center
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Legacy Health System
Total Contact
Investigators
Principal Investigator: Helen Christians, ORT/L Legacy Health System
  More Information

No publications provided

Responsible Party: Helens Christians, Principal Investigator, Legacy Health System
ClinicalTrials.gov Identifier: NCT00242970     History of Changes
Other Study ID Numbers: OBC3DS-01
Study First Received: October 20, 2005
Last Updated: March 31, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Burns
Cicatrix, Hypertrophic
Cicatrix
Fibrosis
Pathologic Processes
Wounds and Injuries

ClinicalTrials.gov processed this record on April 16, 2015