Clinical trial NCT03888703: The Use of Fractional Ablative CO2 Laser vs Control on Acute Traumatic Injuries to Prevent Scar Formation
Official title: Early Intervention of Fractional Ablative CO2 Laser With or Without 830 nm LED Phototherapy for Acute Burn Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scar
Trauma Injury
Burns
Wound Heal
Early Medical Intervention
Laser Therapy
Keywords: early laser intervention
scar prevention
laser resurfacing
wound healing
Lead sponsor: Miami Dermatology and Laser Institute
Sponsor class: OTHER
Collaborators: name: LUTRONIC Corporation
First posted: 2019-03-25
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each subject possessed extensive burn wounds. Wounds on each subject were divided into treatment arms of intervention with fractional ablative CO2 laser and control.
Primary purpose: TREATMENT

Brief summary: Surgical standard for treating traumatic burn injury scarring is to wait one year following the initial assault prior to beginning treatment. This study investigates the use of fractional ablative CO2 laser when begun within 3 months of a traumatic burn injury and it's impact on scar formation compared to the control. We hypothesized that early intervention would substantially mitigate the formation of scar tissue and help restore more normal appearing skin.


Eligibility criteria: 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

Primary outcomes:
measure: Manchester Scar Scale
timeFrame: From the day of the first treatment prior to intervention and at 6 months following the final treatment
measure: Digital photography
timeFrame: From the day of the first treatment prior to intervention and at 6 months following the final treatment
measure: Changes in scar characteristics such as dermal and epidermal character as well as vascular structure and organization assessed through histology.
timeFrame: From the day of the first treatment prior to intervention and at 6 months following the final treatment
Secondary outcomes:
measure: Optical Coherence Tomography
timeFrame: From the day of the first treatment prior to intervention and at 6 months following the final treatment
measure: Treatment Time
timeFrame: Treatment time was measured at each of the three treatments conducted on day 0, day 60, and day 120
measure: Severity of post treatment cutaneous responses as evaluated by the investigator
timeFrame: Post treatment response was assessed immediately post treatment at each of the three treatments conducted on day 0, day 60, and day 120
Other outcomes:
Locations:
Study officials:
References:
citation: Waibel JS, Gianatasio C, Rudnick A. Randomized, Controlled Early Intervention of Dynamic Mode Fractional Ablative CO2 Laser on Acute Burn Injuries for Prevention of Pathological Scarring. Lasers Surg Med. 2020 Feb;52(2):117-124. doi: 10.1002/lsm.23170. Epub 2019 Oct 20.