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

NCT02115646 | Completed Results DMC

• 1 other identifier: 2011P001310
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Burn Scars

Keywords

burn; scar

Outcome Measures

Primary Outcomes (3)

• Scar Pigmentation, Baseline vs 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

  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

  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 Outcomes (2)

• Quality of Life

  Baseline and 15 months

• POSAS

  Baseline and 15 months

Study Arms (1)

fractionated carbon dioxide laser

EXPERIMENTAL

fractionated carbon dioxide laser

Device: fractionated carbon dioxide laser

Interventions

fractionated carbon dioxide laser DEVICE

patients will have serial laser treatments

Also known as: UltraPulse, Lumenis

fractionated carbon dioxide laser

Eligibility Criteria

• Age: 5 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Shriners Hospitals for Children: collaborator
• United States Department of Defense: collaborator

Study Sites (1)

Shriners Hospital- Boston

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Miletta N, Siwy K, Hivnor C, Clark J, Shofner J, Zurakowski D, Anderson RR, Lee K, Donelan M. Fractional Ablative Laser Therapy is an Effective Treatment for Hypertrophic Burn Scars: A Prospective Study of Objective and Subjective Outcomes. Ann Surg. 2021 Dec 1;274(6):e574-e580. doi: 10.1097/SLA.0000000000003576.

  PMID: 31469749 DERIVED

MeSH Terms

Conditions

Burns; Cicatrix

Condition Hierarchy (Ancestors)

Wounds and Injuries; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Kachiu Lee, MD
• Organization: MGH Wellman Center

klee52@partners.org

4018303128

Study Officials

• Richard R Anderson, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2013
• First Posted: April 16, 2014
• Study Start: December 1, 2011
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: June 26, 2018
• Results First Posted: May 15, 2018

Record last verified: 2018-05

Locations

US (1)