- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00242970
Hypertrophic Scarring After Facial Burn
March 31, 2015 updated by: Helens Christians, Legacy Health System
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
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.
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oregon
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Portland, Oregon, United States, 97227
- Legacy Emanuel Hospital and Health Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Study population includes patients with burn injuries to their face and or neck.
Description
Inclusion Criteria:
- Face and/or Neck Burn
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Scar maturation
Time Frame: 5.5 years
|
Can a 3-D scanner measure static and dynamic changes
|
5.5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Helen Christians, ORT/L, Legacy Health System
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
February 1, 2011
Study Completion (Actual)
February 1, 2011
Study Registration Dates
First Submitted
October 20, 2005
First Submitted That Met QC Criteria
October 20, 2005
First Posted (Estimate)
October 21, 2005
Study Record Updates
Last Update Posted (Estimate)
April 3, 2015
Last Update Submitted That Met QC Criteria
March 31, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OBC3DS-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.