ScarNCT03888703
The Use of Fractional Ablative CO2 Laser vs Control on Acute Traumatic Injuries to Prevent Scar Formation
A study testing Fractional ablative CO2 laser in people with Scar and Trauma Injury, run by Miami Dermatology and Laser Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Scar, Trauma Injury, Burns
- What is being tested?
- Fractional ablative CO2 laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- 4 May 2015to 5 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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
About this study
Official title: 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.
- Conditions
- Scar, Trauma Injury, Burns, Wound Heal, Early Medical Intervention, Laser Therapy
- Being tested
- Fractional ablative CO2 laser
- Keywords
- early laser intervention, scar prevention, laser resurfacing, wound healing
- Medical subject headings
- Cicatrix, Accidental Injuries, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional ablative CO2 laserDevice
Three treatments with a fractional ablative CO2 laser 8 weeks apart
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Device: Fractional ablative CO2 laser |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the day of the first treatment prior to intervention and at 6 months following the final treatment
Digital photography
Visual improvement as demonstrated in digital photography. Before and after photos identified by blinded evaluators
Measured: 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.
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.
Measured: From the day of the first treatment prior to intervention and at 6 months following the final treatment
Secondary outcomes (3)
Optical Coherence Tomography
Patients were scanned using OCT for noninvasive skin imaging of both control and treatment areas
Measured: From the day of the first treatment prior to intervention and at 6 months following the final treatment
Treatment Time
The total duration of each treatment was measured in minutes to assess treatment characteristics for large surface areas
Measured: 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
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.
Measured: Post treatment response was assessed immediately post treatment at each of the three treatments conducted on day 0, day 60, and day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start4 May 2015
- Primary completion5 May 2017
- Study completion5 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miami Dermatology and Laser Institute
- Sponsor type
- University, hospital or other
- Collaborators
- CynosureLutronic
- Responsible party
- Principal investigator, Jill Waibel, Miami Dermatology and Laser Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888703
- Sponsor's protocol ID
- SAIRB-13-0045
- Status last verified
- Mar 2019
- First submitted
- 6 Mar 2019
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31631361
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intervention of Fractional Ablative CO2 Laser With or Without 830 nm LED Phototherapy for Acute Burn Injuries
- ClinicalTrials.gov ID
- NCT03888703
- Acronym / sponsor ID
- SAIRB-13-0045
- Conditions
- Scar, Trauma Injury, Burns, Wound Heal, Early Medical Intervention, Laser Therapy
- Keywords
- early laser intervention, scar prevention, laser resurfacing, wound healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Miami Dermatology and Laser InstituteUniversity, hospital or other
- Collaborators
- CynosureLutronic
- Study start
- 4 May 2015 (actual)
- Primary completion
- 5 May 2017 (actual)
- Study completion
- 5 May 2017 (actual)
- First posted
- 25 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Fractional ablative CO2 laser |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractional ablative CO2 laserThree treatments with a fractional ablative CO2 laser 8 weeks apart | Device | Treatment |
Primary outcome
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.
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
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.
3 secondary outcomes
Optical Coherence Tomography
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
- Derived from this study: PubMed 31631361Waibel 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.
- Individual participant dataSharing planned: No
Related trials for Scar
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
RecruitingPhase 2
Tirzepatide for Treatment of CCCA
Central Centrifugal Cicatricial Alopecia (CCCA)
Recruiting
Surgical Outcomes of Simple Interrupted Versus Running Epidermal Sutures in Full-thickness Skin Graft Placement
Skin Graft Scar
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional ablative CO2 laser in people with Scar and Trauma Injury, run by Miami Dermatology and Laser Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manchester Scar Scale (time frame: From the day of the first treatment prior to intervention and at 6 months following the final treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03888703, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2019.