To Study Gene Expression of Postburn Hypertrophic Scar

August 28, 2012 updated by: National Taiwan University Hospital
Aim: To compare the gene expression of postburn hypertrophic scar with normal skin.

Study Overview

Status

Unknown

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

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Principal Investigator:
          • Kean Eng Yeong, College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patient have hypertrophic scar.

Description

Inclusion Criteria:

  • age20~80, hypertrophic scar patient

Exclusion Criteria:

  • no specific limitation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Kean Eng Yeong, college, NTUH Burn lab

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ANTICIPATED)

July 1, 2013

Study Registration Dates

First Submitted

August 28, 2012

First Submitted That Met QC Criteria

August 28, 2012

First Posted (ESTIMATE)

August 30, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 30, 2012

Last Update Submitted That Met QC Criteria

August 28, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • 201205098RIC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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