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To Study Gene Expression of Postburn Hypertrophic Scar

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ClinicalTrials.gov Identifier: NCT01676168
Recruitment Status : Unknown
Verified August 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : August 30, 2012
Last Update Posted : August 30, 2012
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
Aim: To compare the gene expression of postburn hypertrophic scar with normal skin.

Condition or disease
Cicatrix, Hypertrophic

Detailed Description:

Background: Postburn hypertrophic scar (HS) remains a challenging problem. Although varied clinical therapeutic methods have been used, none of them has been widely accepted as a standard care. As hypertrophic scar is hereditary, gene therapy can be a potential tool for scar treatment. To investigate the correlation between the clinical presentation of the hypertrophic scar and its gene expression, we propose an analysis of gene expression in the hypertrophic scar using DNA microarray and Real-Time Quantitative PCR. The study result may form the base of clinical treatment.

Methods and Materials: Thirty scar patients requiring surgical treatment in NTUH burn center will be enrolled into the study. Inclusion criteria: (1) Age between 20 and 80 (2) Patients with postburn hypertrophic scar require surgical treatment.

  1. Hypertrophic scar and normal skin collection: Under Clinical Trial Informed Consent of Research Ethic Committee, scar and normal skin specimen of 1x1cm2 each will be collected and transported to tissue bank with a vacuum low temperature container. The specimen will be kept in a -80℃ refrigerator.
  2. RNA extraction from skin tissue: The RNA extraction will be performed using kit available in the market. Spectrophotometer and gel electrophoresis will be used to measure the purity and concentration of RNA.
  3. Gene expression analysis: DNA microarray and Real-Time Quantitative PCR will be used to analyze RNA expression of hypertrophic scar and normal skin.

Statistics: Student's t-test will be used to compare statistically gene expression between hypertrophic scar and normal skin. P < 0.05 will be considered as statistical significance.


Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: To Study Gene Expression of Postburn Hypertrophic Scar
Study Start Date : July 2012
Estimated Primary Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
hypertrophic scar
1x1cm2 hypertrophic scar of post-burn patients are taked by visiting staff when they accept scar-reconstructive surgery.
normal skin
When the patient accept skin grafting surgery, visiting staff will take 1x1cm2 normal skin.



Biospecimen Retention:   Samples With DNA
Hypertrophic scar from post-burn patient


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patient have hypertrophic scar.
Criteria

Inclusion Criteria:

  • age20~80, hypertrophic scar patient

Exclusion Criteria:

  • no specific limitation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01676168


Contacts
Contact: Kean Eng Yeong, college 886-2-23123456 ext 65648 smartpace88@hotmail.com

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Contact: Kean Eng Yeong, college    886-2-23123456 ext 65648    smartpace88@hotmail.com   
Principal Investigator: Kean Eng Yeong, College         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Chair: Kean Eng Yeong, college NTUH Burn lab

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01676168     History of Changes
Other Study ID Numbers: 201205098RIC
First Posted: August 30, 2012    Key Record Dates
Last Update Posted: August 30, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Hypertrophy
Cicatrix
Cicatrix, Hypertrophic
Pathological Conditions, Anatomical
Fibrosis
Pathologic Processes