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NCT00242970 Clinical Trial

Hypertrophic Scarring After Facial Burn

Burn Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00242970
Other study ID # OBC3DS-01
Secondary ID
Status Completed
Phase Phase 2
First received October 20, 2005
Last updated March 31, 2015
Start date October 2005
Est. completion date February 2011

Study information
Verified date March 2015
Source Legacy Health System
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date February 2011
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Both
Age group 4 Years to 70 Years
Eligibility Inclusion Criteria:

- Face and/or Neck Burn

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• 3-Dimensional Color Scanning
Color imaging of the face and neck.

Locations
Country Name City State
United States Legacy Emanuel Hospital and Health Center Portland Oregon

Sponsors (2)
Lead Sponsor Collaborator
Legacy Health System Total Contact

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Scar maturation Can a 3-D scanner measure static and dynamic changes 5.5 years No
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