- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04176705
Fractional Ablative Laser Treatment for Skin Grafts
Pilot Study of Early Postoperative Fractional Ablative Laser Treatment of Skin Grafts for Burns
Doctors and patients refer to all areas of skin changes from burn injury as burn scars. However, different areas of scars from burns can be treated differently. The burn scars that come from skin grafting surgery might be improved with laser treatment. The purpose of this study is to see if treating burn skin graft scars with a laser could make it better.
Fractional Ablative Laser has been approved by the US Food and Drug Administration (FDA), but it has not been approved for use in the early stages of scar maturation and is considered investigational for this study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: D'Ann Hershel
- Phone Number: 336-716-1659
- Email: dhershel@wakehealth.edu
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest Baptist Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients who are to undergo skin grafting procedures for acture treatment of thermal burns.
- Patients with grafts placed over at least 100cm^2
Exclusion Criteria:
- Patients who have are not scheduled to undergo skin grafting procedures
- Patients who have grafts placed under 100cm^2
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Laser
|
Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.
Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.
Applied to only site that is randomized to laser intervention
|
Placebo Comparator: No laser
|
Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.
Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Contracture of Scar Surface Area
Time Frame: 90 days post-grafting
|
Contracture of Scar Surface Area 90 days post grafting: The surface area of the skin graft cm^2 at about 90 days after skin grafting will be compared to the size of the original skin graft at about one week after surgery.
|
90 days post-grafting
|
Contracture of Scar Surface Area
Time Frame: 1 year post-grafting
|
Contracture of Scar Surface Area 1 year post grafting: The surface area of the skin graft cm^2 at about one year after skin grafting will be compared to the size of the original skin graft at about one week after surgery.
|
1 year post-grafting
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Scar Roughness
Time Frame: 90 days post-grafting
|
Scar Roughness at 9 weeks and 12 weeks post grafting: will be quantified using a mold/casting technique using Aquasil Ultra XLV dental impression material followed by mold imaging and quantitative analysis.
A three-dimensional analysis of the molds will allow for measure of average roughness.
The machine used will provide a digital read out which will then be averaged to obtain a mean value.
This will allow for comparison between treated and control grafts at 90 days and one year.
|
90 days post-grafting
|
Scar Roughness
Time Frame: 1 year post-grafting
|
Scar Roughness 10-12 months post grafting: will be quantified using a mold/casting technique using Aquasil Ultra XLV dental impression material followed by mold imaging and quantitative analysis.
A three-dimensional analysis of the molds will allow for measure of average roughness.
The machine used will provide a digital read out that will then be averaged to obtain a mean value.
This will allow for comparison between treated and control grafts at 90 days and one year.
|
1 year post-grafting
|
Biomechanics Stiffness
Time Frame: 90 days post-grafting
|
Biomechanics Stiffness 90 days post grafting: The BTC-2000 device uses a laser to measure skin deflection as negative atmospheric pressure is applied and this allows for quantification of the skin's mechanical properties (e.g.
elasticity and stiffness).
The device will provide a digital readout that will be averaged to obtain a mean value.
|
90 days post-grafting
|
Biomechanics Stiffness
Time Frame: 1 year post-grafting
|
Biomechanics Stiffness 10-12 months post grafting: The BTC-2000 device uses a laser to measure skin deflection as negative atmospheric pressure is applied and this allows for quantification of the skin's mechanical properties (e.g.
elasticity and stiffness).
The device will provide a digital readout that will be averaged to obtain a mean value.
|
1 year post-grafting
|
Biomechanics Elasticity
Time Frame: 90 days post-grafting
|
Elasticity will be quantified using a BTC-2000, a high resolution Target Laser and negative pressure transducer.
The BTC-2000 device uses a laser to measure skin deflection as negative atmospheric pressure is applied and this allows for quantification of the skin's mechanical properties (e.g.
elasticity and stiffness).
The device will provide a digital readout that will be averaged to obtain a mean value.
|
90 days post-grafting
|
Biomechanics Elasticity
Time Frame: 1 year post-grafting
|
Elasticity will be quantified using a BTC-2000, a high resolution Target Laser and negative pressure transducer.
The BTC-2000 device uses a laser to measure skin deflection as negative atmospheric pressure is applied and this allows for quantification of the skin's mechanical properties (e.g.
elasticity and stiffness).
The device will provide a digital readout that will be averaged to obtain a mean value.
|
1 year post-grafting
|
Erythema
Time Frame: 90 days post-grafting
|
Erythema will be measured using a Mexameter that will accurately measure even small changes in erythema levels, then provide a digital read out from which an average mean can be obtained.
|
90 days post-grafting
|
Erythema
Time Frame: 1 year post-grafting
|
Erythema will be measured using a Mexameter that will accurately measure even small changes in erythema levels, then provide a digital read out from which an average mean can be obtained.
|
1 year post-grafting
|
Vancouver Scar Scale (VSS)
Time Frame: 90 days post-grafting
|
Scar-rating scale that objectively evaluates scar properties to include the following: Vascularity: Normal = 0, Pink=1, Red = 2, Purple = 3; Pigmentation: Normal= 0, Hypopigmentation= 1, Hyperpigmentation= 2; Pliability: Normal= 0, Supple =1, Yielding= 2, Firm= 3, Ropes= 4, Contracture= 5; Height: Flat= 0, <2mm=1, 2-5mm=2, >5mm=3; Lowest possible score= 0 and Highest Score possible = 13.
Higher results denotes worse outcomes.
|
90 days post-grafting
|
Vancouver Scar Scale (VSS)
Time Frame: 1 year post-grafting
|
Scar-rating scale that objectively evaluates scar properties to include the following: Vascularity: Normal = 0, Pink=1, Red = 2, Purple = 3; Pigmentation: Normal= 0, Hypopigmentation= 1, Hyperpigmentation= 2; Pliability: Normal= 0, Supple =1, Yielding= 2, Firm= 3, Ropes= 4, Contracture= 5; Height: Flat= 0, <2mm=1, 2-5mm=2, >5mm=3; Lowest possible score= 0 and Highest Score possible = 13.
Higher results denotes worse outcomes.
|
1 year post-grafting
|
Patient and Observer Scar Assessment Scale (POSAS)--Patient
Time Frame: 90 days post-grafting
|
Subjective scar scale for the patient that measures perception of scar height, pliability, pigmentation, vascularization, and relief.
Scores ranging from 1 meaning no complaint to 10 meaning worst scar imaginable for the patient assessment.
|
90 days post-grafting
|
Patient and Observer Scar Assessment Scale (POSAS)--Observer
Time Frame: 90 days post-grafting
|
Subjective scar scale for the observer that measures perception of scar height, pliability, pigmentation, vascularization, and relief.
For the observer assessment, score ranges from 1-10 with one indicating normal skin and ten indicating the worst scar imaginable.
|
90 days post-grafting
|
Patient and Observer Scar Assessment Scale (POSAS)--Patient
Time Frame: 1 year post-grafting
|
Subjective scar scale for the patient that measures perception of scar height, pliability, pigmentation, vascularization, and relief.
Scores ranging from 1 meaning no complaint to 10 meaning worst scar imaginable for the patient assessment.
|
1 year post-grafting
|
Patient and Observer Scar Assessment Scale (POSAS)--Observer
Time Frame: 1 year post-grafting
|
Subjective scar scale for the observer that measures perception of scar height, pliability, pigmentation, vascularization, and relief.
For the observer assessment, score ranges from 1-10 with one indicating normal skin and ten indicating the worst scar imaginable.
|
1 year post-grafting
|
Patient-Reported Satisfaction
Time Frame: 90 days post-grafting
|
Subjective measurement of patient satisfaction of outcome based on a 0-10 Likert scale with 10 being the best outcome.
|
90 days post-grafting
|
Patient-Reported Satisfaction
Time Frame: 1 year post-grafting
|
Subjective measurement of patient satisfaction of outcome based on a 0-10 Likert scale with 10 being the best outcome.
|
1 year post-grafting
|
Collaborators and Investigators
Investigators
- Principal Investigator: John Bailey, MD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Fibrosis
- Cicatrix
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
- Triamcinolone
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
Other Study ID Numbers
- IRB00058363
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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