Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02115646
Recruitment Status : Completed
First Posted : April 16, 2014
Results First Posted : May 15, 2018
Last Update Posted : June 26, 2018
Sponsor:
Collaborators:
Shriners Hospitals for Children
United States Department of Defense
Information provided by (Responsible Party):
Richard Rox Anderson, MD, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Burn Scars Device: fractionated carbon dioxide laser Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fractionated Carbon Dioxide Laser and Burn Scar Contractures: Evaluation of Post-Treatment Scar Function and Appearance
Study Start Date : December 2011
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns Scars

Arm Intervention/treatment
Experimental: fractionated carbon dioxide laser
fractionated carbon dioxide laser
Device: fractionated carbon dioxide laser
patients will have serial laser treatments
Other Name: UltraPulse, Lumenis




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02115646


Locations
Layout table for location information
United States, Massachusetts
Shriners Hospital- Boston
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Shriners Hospitals for Children
United States Department of Defense
Investigators
Layout table for investigator information
Principal Investigator: Richard R Anderson, MD Massachusetts General Hospital

Layout table for additonal information
Responsible Party: Richard Rox Anderson, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02115646     History of Changes
Other Study ID Numbers: 2011P001310
First Posted: April 16, 2014    Key Record Dates
Results First Posted: May 15, 2018
Last Update Posted: June 26, 2018
Last Verified: May 2018

Keywords provided by Richard Rox Anderson, MD, Massachusetts General Hospital:
burn
scar

Additional relevant MeSH terms:
Layout table for MeSH terms
Burns
Contracture
Cicatrix
Wounds and Injuries
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Fibrosis
Pathologic Processes