To Study Gene Expression of Postburn Hypertrophic Scar

Cicatrix, Hypertrophic Clinical Trial

Official title:

To Study Gene Expression of Postburn Hypertrophic Scar

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01676168
• Other study ID #: 201205098RIC
• Status: Recruiting
• Phase: N/A
• First received: August 28, 2012
• Last updated: August 28, 2012
• Start date: July 2012

Study information

• Verified date: August 2012
• Source: National Taiwan University Hospital
• Contact: Kean Eng Yeong, college
• Phone: 886-2-23123456
• Email: smartpace88[@]hotmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• age20~80, hypertrophic scar patient

Exclusion Criteria:

• no specific limitation

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cicatrix, Hypertrophic
• Hypertrophy

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan,