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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

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

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

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

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

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

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

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

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

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

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