Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-28 @ 4:17 PM
Study NCT ID:
NCT01676168
Status:
UNKNOWN
Last Update Posted:
2012-08-30
First Post:
2012-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Study Gene Expression of Postburn Hypertrophic Scar
Sponsor:
National Taiwan University Hospital
Organization:
Study Overview
Official Title:
To Study Gene Expression of Postburn Hypertrophic Scar
Status:
UNKNOWN
Status Verified Date:
2012-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aim: To compare the gene expression of postburn hypertrophic scar with normal skin.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: