The Use of Fractional Ablative CO2 Laser vs Control on Acute Traumatic Injuries to Prevent Scar Formation

Inclusion criteria

• Subject is between 18 and 80 years of age with burn injuries suffered within the prior 3 months
• Subject is a healthy Male or Female
• Fitzpatrick Skin Type I - IV
• Subject must have moderate - severe burn damage of sufficient bilateral area involving either the face, trunk, arms or legs
• Subject must be able to read, understand and sign the Informed Consent Form
• Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions
• Subject must be willing to have limited sun exposure for the duration of the study, including the follow-up period
• Subject is willing to have photographs taken of the treated area which will be used de-identified in evaluations and may be used de-identified in presentations and/or publications
• For female candidates - they may be post-menopausal, surgically sterilized, or using a medically acceptable form of birth control during the entire course of the study.
• Female candidates with child bearing potential - willing to take pregnancy test and result must be negative.

Exclusion criteria

• Subject is less than 18 or greater than 80 years of age.
• Subject has Fitzpatrick Skin Type V - VI
• Subject is Pregnant or planning to become pregnant during the study duration
• Subject is breast feeding during the study duration
• Subject has an active skin infection, dermatitis or a rash in the treatment area
• Subject has a history of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications
• Subject has a known bleeding disorder
• Subject has a known photosensitivity to the study laser wavelength, history of ingesting medications known to induce photosensitivity, or history of seizure disorders due to light.
• Subject has a known collagen, vascular disease or scleroderma
• Subject has undergone any surgery or other procedures in the treatment area within 6 months of treatment which are still healing.
• Subject is suffering from significant concurrent illness, such as insulin-dependent diabetes, peripheral vascular disease or peripheral neuropathy
• Subject is undergoing systemic chemotherapy for the treatment of cancer
• Subject has lesions suspicious for malignancy
• The systemic use of isotretinoin (Accutane®) or other retinoid derivatives within 6 months of study participation
• Any use of gold therapy for disorders such as rheumatologic disease or lupus
• The subject is excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study
• The subject has participated in a study of another device or drug within three months prior to enrollment or during the study.
• As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study