Clinical trial NCT02115646: Fractionated Carbon Dioxide Laser and Burn Scar Contractures: Evaluation of Post-Treatment Scar Function and Appearance
Official title: Fractionated Carbon Dioxide Laser and Burn Scar Contractures: Evaluation of Post-Treatment Scar Function and Appearance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burn Scars
Keywords: burn
scar
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Shriners Hospitals for Children
name: United States Department of Defense
First posted: 2014-04-16
Enrollment: 29
Sex: ALL
Minimum age (years): 5
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Scar Pigmentation, Baseline vs 15-months
timeFrame: Baseline and 15 months
measure: Scar Elasticity, Baseline vs 15-months
timeFrame: Baseline and 15 months
measure: Scar Thickness
timeFrame: Baseline and 15 months
Secondary outcomes:
measure: Quality of Life
timeFrame: Baseline and 15 months
measure: POSAS
timeFrame: Baseline and 15 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Shriners Hospital- Boston
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Richard R Anderson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.