Fractional Photothermolysis for the Treatment of Burn Scars

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Clinica las Condes, Chile.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Corporacion de ayuda al niño quemado (COANIQUEM)
Solta Medical
Information provided by:
Clinica las Condes, Chile
ClinicalTrials.gov Identifier:
NCT01005992
First received: October 30, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

The aim of our study is to determine the effect of fractional photothermolysis laser in the treatment of burn scars.


Condition Intervention Phase
Scar
Procedure: Fractional laser treatment
Procedure: Standard scar management
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fractional Photothermolysis for the Treatment of Burn Scars

Resource links provided by NLM:


Further study details as provided by Clinica las Condes, Chile:

Primary Outcome Measures:
  • Evidence of improvement in color and texture of burn scars, using digital colorimeter and digital photography. [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Adverse effects: pain, erythema, edema, hypopigmentation, hyperpigmentation, hypertrophic scar and keloid formation [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in surface area and perimeter of burn scar [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Tissue pliability, elevation and flexibility with a digital piedemeter [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Change in collagen fiber organization and blood vessel density with a reflectance laser confocal microscope. [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: November 2009
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laser treated scar
The standard treated scar arm consists of a similar lesion in an equivalent location in the same patient or the half of a lesion that is suitable to be divided (size at least 4% body surface area). This arm will be managed only with standard burn treatment modalities.
Procedure: Fractional laser treatment
A complete treatment will consist in four laser sessions with a second-generation erbium-doped 1,550-nm fractional photothermolysis laser (Fraxel SR laser, Reliant Technologies Inc at 1-month intervals. Treatment will be delivered with a 15-mm tip and concomitant air-cooling system (Zimmer MedizinSystems, Irvine, CA). Fluence and treatment level will be registered on every session and will be adjusted according to patient tolerance.
Active Comparator: Standard scar management
The standard scar management arm consists of a similar lesion in an equivalent location in the same patient or the half of a lesion that is suitable to be divided (size at least 4% body surface area). This arm will be managed only with standard burn treatment modalities.
Procedure: Standard scar management
The standard treated scar arm consists of a similar lesion in an equivalent location in the same patient or the half of a lesion that is suitable to be divided (size at least 4% body surface area). This arm will be managed only with standard burn treatment modalities.

Detailed Description:

One of the main problems in the management of burned patients is the treatment of post-burn scarring. Frequently this scars cover large areas, tend to retract, present pigmentary changes and are disfiguring, producing significant life quality impairment.

Unfortunately, there are very few therapeutic options for treating these scars, which can be secondary to reconstructive surgery or after spontaneous healing. In the last decades most reports in scar treatment have included, pressure garments, chemical peeling, dermabrasion, ablative and non-ablative laser therapy and surgery with varying degrees of success. There is only one report treating burn scars with fractional laser, with good results.

The aim of our study is to determine the effect of of a second-generation erbium-doped 1,550-nm fractional photothermolysis laser (Fraxel SR laser, Reliant Technologies Inc.) in the treatment of burn scars.

  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Burn scars should be located on the anterior thorax or abdomen with at least 4 months of evolution.
  • The scar should be slightly elevated, with erythema and with no signs of keloid formation.
  • Maximum scar dimension: 0.2 - 1% body surface area.
  • Acceptance of informed consent for laser treatment.

Exclusion Criteria:

  • Previous non-surgical treatment (i.e. dermabrasion, laser, peelings, bleaching agent. etc).
  • Previous surgical treatment (i.e. graft)
  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: NCT01005992

Contacts
Contact: Rodrigo Schwartz, MD 56-2-6108661 schwartz.rodrigo@gmail.com

Locations
Chile
Clinica Las Condes Not yet recruiting
Santiago, RM, Chile
Contact: Rodrigo J Schwartz, MD    56-2-6108661      
Contact: Fresia Solias       investigacion@coaniquem.cl   
Principal Investigator: Rodrigo J Schwartz, MD         
Sub-Investigator: Fresia Solis         
Sub-Investigator: Gonzalo Eguiguren, MD         
Sub-Investigator: Jorge Rojas, MD         
Sub-Investigator: pedro lobos, MD         
Sub-Investigator: Patricia Apt, MD         
Sponsors and Collaborators
Clinica las Condes, Chile
Corporacion de ayuda al niño quemado (COANIQUEM)
Solta Medical
Investigators
Principal Investigator: Rodrigo J Schwartz, MD Clinica Las Condes
  More Information

Publications:
Responsible Party: Rodrigo Schwartz M.D., Clinica Las Condes
ClinicalTrials.gov Identifier: NCT01005992     History of Changes
Other Study ID Numbers: CLCCQFQ-1
Study First Received: October 30, 2009
Last Updated: October 30, 2009
Health Authority: Chile: Instituto de Salud Pública de Chile

Keywords provided by Clinica las Condes, Chile:
Scars secondary to injuries to tissues caused by contact with physical (heat, electricity) o chemical agent.

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014