The Use of Fractional Ablative CO2 Laser vs Control on Acute Traumatic Injuries to Prevent Scar Formation
March 22, 2019 updated by: Jill Waibel, Miami Dermatology and Laser Institute
Early Intervention of Fractional Ablative CO2 Laser With or Without 830 nm LED Phototherapy for Acute Burn Injuries
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: Control
|
|
|
EXPERIMENTAL: Treatment
|
Three treatments with a fractional ablative CO2 laser 8 weeks apart
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Manchester Scar Scale
Time Frame: From the day of the first treatment prior to intervention and at 6 months following the final treatment
|
The sum total of the Manchester Scar Scale to assess the change in scar characteristics.
The scale includes the following categories: Color, matte vs shiny, contour, distortion, and texture.
Scales for color, contour, distortion, and texture are rated on a 1-4 scale with 1 being most normal and 4 being most abnormal.
Matte vs shiny is rated on a 1 to 2 scale with 1 being matte and 2 being shiny.
Assessments completed by blinded evaluators.
A decrease in score indicates improvement in scar characteristics.
|
From the day of the first treatment prior to intervention and at 6 months following the final treatment
|
|
Digital photography
Time Frame: From the day of the first treatment prior to intervention and at 6 months following the final treatment
|
Visual improvement as demonstrated in digital photography.
Before and after photos identified by blinded evaluators
|
From the day of the first treatment prior to intervention and at 6 months following the final treatment
|
|
Changes in scar characteristics such as dermal and epidermal character as well as vascular structure and organization assessed through histology.
Time Frame: From the day of the first treatment prior to intervention and at 6 months following the final treatment
|
Some patients elected to do optional biopsies for deeper evaluation of changes in skin structure.
Biopsies were taken prior to treatment and 6 months following treatment to assess dermal and epidermal character as well as the size and organization of vasculature.
Evaluation was done qualitatively.
|
From the day of the first treatment prior to intervention and at 6 months following the final treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Optical Coherence Tomography
Time Frame: From the day of the first treatment prior to intervention and at 6 months following the final treatment
|
Patients were scanned using OCT for noninvasive skin imaging of both control and treatment areas
|
From the day of the first treatment prior to intervention and at 6 months following the final treatment
|
|
Treatment Time
Time Frame: Treatment time was measured at each of the three treatments conducted on day 0, day 60, and day 120
|
The total duration of each treatment was measured in minutes to assess treatment characteristics for large surface areas
|
Treatment time was measured at each of the three treatments conducted on day 0, day 60, and day 120
|
|
Severity of post treatment cutaneous responses as evaluated by the investigator
Time Frame: Post treatment response was assessed immediately post treatment at each of the three treatments conducted on day 0, day 60, and day 120
|
Cutaneous responses including purpura, edema, erythema, hyperpigmentation, hypopigmentation, blistering and scarring were assessed following each treatment.
Areas were rated on a 1-4 scale where 1 = none, 2 = mild, 3 = moderate, and 4 = severe.
|
Post treatment response was assessed immediately post treatment at each of the three treatments conducted on day 0, day 60, and day 120
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 4, 2015
Primary Completion (ACTUAL)
May 5, 2017
Study Completion (ACTUAL)
May 5, 2017
Study Registration Dates
First Submitted
March 6, 2019
First Submitted That Met QC Criteria
March 22, 2019
First Posted (ACTUAL)
March 25, 2019
Study Record Updates
Last Update Posted (ACTUAL)
March 25, 2019
Last Update Submitted That Met QC Criteria
March 22, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAIRB-13-0045
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.