Fractionated Carbon Dioxide Laser and Burn Scar Contractures: Evaluation of Post-Treatment Scar Function and Appearance

May 26, 2018 updated by: Richard Rox Anderson, MD, Massachusetts General Hospital
The investigators are studying the appearance and function of burn scars after treatment with fractionated carbon dioxide laser. The investigators hypothesize that the cosmetic appearance and range of motion will improve with treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary goal of the study will analyze whether the fractionated carbon dioxide laser can improve other subjective and objective qualities of hypertrophic and/or contracted burn scars with or without involvement of nearby mobile joints.

The investigators hypothesize that fractionated carbon dioxide laser therapy will increase range of motion and improve tissue compliance in all scars overlying a mobile joint that has been limited due to burn scar contracture. In addition, the investigators will evaluate the effect of fractionated carbon dioxide laser therapy on common sequelae of hypertrophic and/or contracted burn scars.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Shriners Hospital- Boston

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

5 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy males and females between 5 and 70 years of age with hypertrophic and/or contracted burn scars with or without involvement of mobile joints. The burn scars must have occurred at least 1 year prior to the date of enrollment.
  • Having suitable areas of treatment: All wounds in the area of interest must be closed for at least two months, and the scars must be deemed stable for a period of 3 months before initiation of treatment.
  • Fitzpatrick skin types I-VI
  • Able and willing to comply with all visit, treatment and evaluation schedules and requirements
  • Able to understand provide written informed consent
  • Women of child-bearing age are required to be using a reliable method of birth control at least three months prior to study enrollment and throughout the course of the study.

Exclusion Criteria:

  • Pregnant, intending to become pregnant during the course of the study, less than three months postpartum or less than six weeks after completion of breastfeeding.
  • Active tanning, including the use of tanning booths, during the course of the study
  • Showing symptoms of hormonal disorders (i.e.: uncontrolled thyroid disease or Polycystic Ovary Syndrome), as per the Investigator's discretion
  • Abnormal photosensitivity due to metabolic disorder or due to use of external agents, (drugs, herbs, etc.) within 2 weeks of initial treatment or during the course of the study, except for use of aminolevulinic acid(Levulan®) which requires a washout period of three months
  • Prior use of retinoids in treated areas within three months of initial treatment or during the course of the study
  • Use of oral isotretinoin (Accutane®) within nine months of initial treatment or during the course of the study. Note: skin must retain its normal degree of moisture prior to treatment
  • Prior skin treatment with laser or other devices in the treated area within three months of initial treatment or during the course of the study
  • Adverse reactions to compounds of any external agent (e.g., gels, lotions or anesthetic creams) required for use in the study, if no alternative to the said agent exists
  • History of collagen vascular disease
  • Concurrent inflammatory skin conditions, including, but not limited to, rosacea of any severity
  • Active Herpes Simplex at the time of treatment or having experienced more than three episodes of Herpes Simplex eruption within a year of study enrollment
  • Multiple dysplastic nevi in area to be treated
  • Having a bleeding disorder or taking anticoagulation medications, including heavy use of aspirin, in a manner which does not allow for a minimum 10 day washout period prior to each treatment (as per the patient's physician discretion)
  • History of immunosuppression/immune deficiency disorders (including human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) or use of immunosuppressive medications
  • Having any form of active cancer at the time of enrollment and during the course of the study
  • Significant concurrent illness, such as uncontrolled diabetes, (i.e., any disease state that in the opinion of the Investigator would interfere with the anesthesia, treatment, or healing process)
  • Mentally incompetent, prisoner or evidence of active substance or alcohol abuse
  • Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or study personnel) to treat the subject as part of this research study
  • If it is determined that the contracture is due to a deeper process involving the muscles, ligaments or bones.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: fractionated carbon dioxide laser
Device: fractionated carbon dioxide laser
patients will have serial laser treatments
Other Names:
  • UltraPulse, Lumenis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scar Pigmentation, Baseline vs 15-months
Time Frame: Baseline and 15 months
Using the colorimeter, will measure change in pigmentation of the scar at the conclusion of the study. This tool measures the pigment in a scar, with a possible range of 0-100, with 100 being the darkest hyperpigmentation, and 0 being no hyperpigmentation.
Baseline and 15 months
Scar Elasticity, Baseline vs 15-months
Time Frame: Baseline and 15 months
This is the measure of the elasticity of the scar using a Torque-meter. It is measured on a 0-1 unit scale, with 0 being normal skin elasticity and 1 being completely inelastic.
Baseline and 15 months
Scar Thickness
Time Frame: Baseline and 15 months
This is an ultrasound measurement using the Dermascan Cyberderm to measure the thickness of the scar at baseline in millimeters.
Baseline and 15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: Baseline and 15 months
The 36-Item Short Form Survey (SF-36) is a validated quality of life measurement tool. It measures 8 health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. It is scored on a 0-100 scale, with 100 being the least bothersome to quality of life.
Baseline and 15 months
POSAS
Time Frame: Baseline and 15 months
The Patient and Observer Scar Assessment Scale (POSAS) is a validated scale that measures both the patient assessment and the observer assessment on the quality (height, color, stiffness, thickness, symptoms, relief, surface area) of the scar. Scores range from 0-60, with 60 being the worst quality of scar.
Baseline and 15 months

Collaborators and Investigators

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

Sponsor

Massachusetts General Hospital

Collaborators

United States Department of Defense
Shriners Hospitals for Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2011

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

July 1, 2013

First Submitted That Met QC Criteria

April 15, 2014

First Posted (Estimate)

April 16, 2014

Study Record Updates

Last Update Posted (Actual)

June 26, 2018

Last Update Submitted That Met QC Criteria

May 26, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011P001310

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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