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

NCT ID: NCT02115646

Last Updated: 2018-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2017-01-31

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.

Conditions

Burn Scars

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

fractionated carbon dioxide laser

fractionated carbon dioxide laser

Group Type: EXPERIMENTAL

fractionated carbon dioxide laser

Intervention Type: DEVICE

patients will have serial laser treatments

Interventions

fractionated carbon dioxide laser

patients will have serial laser treatments

Intervention Type: DEVICE

Other Intervention Names

UltraPulse, Lumenis

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shriners Hospitals for Children

OTHER

Sponsor Role: collaborator

United States Department of Defense

FED

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Richard Rox Anderson, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard R Anderson, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Shriners Hospital- Boston

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31469749 (View on PubMed)

Other Identifiers

2011P001310

Identifier Type: -

Identifier Source: org_study_id