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
|Condition or disease|
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.
- 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.
- 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.
- 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|
|Official Title:||To Study Gene Expression of Postburn Hypertrophic Scar|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||July 2013|
1x1cm2 hypertrophic scar of post-burn patients are taked by visiting staff when they accept scar-reconstructive surgery.
When the patient accept skin grafting surgery, visiting staff will take 1x1cm2 normal skin.
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
|Contact: Kean Eng Yeong, college||886-2-23123456 ext firstname.lastname@example.org|
|National Taiwan University Hospital||Recruiting|
|Taipei, Taiwan, 10002|
|Contact: Kean Eng Yeong, college 886-2-23123456 ext 65648 email@example.com|
|Principal Investigator: Kean Eng Yeong, College|
|Study Chair:||Kean Eng Yeong, college||NTUH Burn lab|