To Study Gene Expression of Postburn Hypertrophic Scar

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01676168
First received: August 28, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

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


Condition
Cicatrix, Hypertrophic

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: To Study Gene Expression of Postburn Hypertrophic Scar

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Biospecimen Retention:   Samples With DNA

Hypertrophic scar from post-burn patient


Estimated Enrollment: 30
Study Start Date: July 2012
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01676168     History of Changes
Other Study ID Numbers: 201205098RIC
Study First Received: August 28, 2012
Last Updated: August 28, 2012
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on August 01, 2014