The Use of Fractional Ablative CO2 Laser vs Control on Acute Traumatic Injuries to Prevent Scar Formation
Primary Purpose
Scar, Trauma Injury, Burns
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fractional ablative CO2 laser
Sponsored by
About this trial
This is an interventional treatment trial for Scar focused on measuring early laser intervention, scar prevention, laser resurfacing, wound healing
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment
Control
Arm Description
Outcomes
Primary Outcome Measures
Manchester Scar Scale
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.
Digital photography
Visual improvement as demonstrated in digital photography. Before and after photos identified by blinded evaluators
Changes in scar characteristics such as dermal and epidermal character as well as vascular structure and organization assessed through histology.
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.
Secondary Outcome Measures
Optical Coherence Tomography
Patients were scanned using OCT for noninvasive skin imaging of both control and treatment areas
Treatment Time
The total duration of each treatment was measured in minutes to assess treatment characteristics for large surface areas
Severity of post treatment cutaneous responses as evaluated by the investigator
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.
Full Information
NCT ID
NCT03888703
First Posted
March 6, 2019
Last Updated
March 22, 2019
Sponsor
Miami Dermatology and Laser Institute
Collaborators
LUTRONIC Corporation
1. Study Identification
Unique Protocol Identification Number
NCT03888703
Brief Title
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
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 4, 2015 (Actual)
Primary Completion Date
May 5, 2017 (Actual)
Study Completion Date
May 5, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Miami Dermatology and Laser Institute
Collaborators
LUTRONIC Corporation
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scar, Trauma Injury, Burns, Wound Heal, Early Medical Intervention, Laser Therapy
Keywords
early laser intervention, scar prevention, laser resurfacing, wound healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
The treatment and control areas were randomized in advanced such that the investigator did not choose which sections to treat. Control areas were covered during the treatment so the investigator/provider could only see areas to be treated. Outcomes assessors evaluated photographs without knowledge of the identity of each area. The participant could not be masked due the experience of receiving treatment.
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Fractional ablative CO2 laser
Intervention Description
Three treatments with a fractional ablative CO2 laser 8 weeks apart
Primary Outcome Measure Information:
Title
Manchester Scar Scale
Description
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.
Time Frame
From the day of the first treatment prior to intervention and at 6 months following the final treatment
Title
Digital photography
Description
Visual improvement as demonstrated in digital photography. Before and after photos identified by blinded evaluators
Time Frame
From the day of the first treatment prior to intervention and at 6 months following the final treatment
Title
Changes in scar characteristics such as dermal and epidermal character as well as vascular structure and organization assessed through histology.
Description
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.
Time Frame
From the day of the first treatment prior to intervention and at 6 months following the final treatment
Secondary Outcome Measure Information:
Title
Optical Coherence Tomography
Description
Patients were scanned using OCT for noninvasive skin imaging of both control and treatment areas
Time Frame
From the day of the first treatment prior to intervention and at 6 months following the final treatment
Title
Treatment Time
Description
The total duration of each treatment was measured in minutes to assess treatment characteristics for large surface areas
Time Frame
Treatment time was measured at each of the three treatments conducted on day 0, day 60, and day 120
Title
Severity of post treatment cutaneous responses as evaluated by the investigator
Description
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.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31631361
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.
Results Reference
derived
Learn more about this trial
The Use of Fractional Ablative CO2 Laser vs Control on Acute Traumatic Injuries to Prevent Scar Formation
We'll reach out to this number within 24 hrs