Burn ScarNCT04176705
Fractional Ablative Laser Treatment for Skin Grafts
A study testing Lidocaine Cream, Triamcinolone Acetonide Cream and Fractional Ablative Laser in people with Burn Scar and Skin Graft Scar, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn Scar, Skin Graft Scar
- What is being tested?
- Lidocaine Cream, Triamcinolone Acetonide Cream and Fractional Ablative Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2020to 29 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are to undergo skin grafting procedures for acute treatment of thermal burns.
- Patients with grafts placed over at least 100cm^2
Who cannot join
- Patients who have are not scheduled to undergo skin grafting procedures
- Patients who have grafts placed under 100cm^2
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the detailed description
This pilot study is being conducted to establish safety, however the study team will make multiple measures to measure for efficacy as well. The study team hypothesizes that human split-thickness skin grafts will safely respond similar to the porcine model when treated with the Fractional Carbon Dioxide (FxCO2) laser and have significantly less secondary contracture than control sites. The great majority of laser studies have addressed treatment of established scars. Ideally, treatment modalities could be moved into the acute period of injury, to shorten the recovery time of thermal burns by decreasing the time to maximum recovery, and mitigate scar formation. The current study will address the impact on treatment of skin graft applied in the treatment of acute burn wounds. Preliminary work completed by our team has confirmed that the red Duroc porcine model is a good model of hypertrophic scar formation in humans, and early use of the FxCO2 on split-thickness skin grafts decreased secondary contracture. Further, the study team has identified a period of 19 weeks between the time custom-made compression garments are ordered and actually applied with benefit to the patient. The study team has identified a "therapeutic donut hole" in which they have no efficacious alternative to offer until about 19 weeks. In these patients who had larger burn returning to the OR for additional procedures, the study team was able to offer FxCO2 treatment as a "salvage" therapy. With this, the study team has demonstrated safety for the skin graft and anecdotal efficacy. The study team proposes a pilot study to prospectively demonstrate safety in a controlled study and attempt to establish efficacy of early (post grafting day 7-10) FxCO2 laser treatment of split-thickness skin graft applied in the treatment of burn injuries.
- Conditions
- Burn Scar, Skin Graft Scar
- Being tested
- Lidocaine Cream, Triamcinolone Acetonide Cream, Fractional Ablative Laser
- Keywords
- Fractional laser, Ablative Laser, Carbon Dioxide Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine CreamDrug
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 CreamDrug
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.
Fractional Ablative LaserDevice
Applied to only site that is randomized to laser intervention
| Study group | Role | What they receive |
|---|---|---|
| Laser | Experimental | Split person design. Each participant had a skin burn area that was treated with the laser and a skin burn area that was not treated with the laser. Receives: Drug: Lidocaine Cream; Drug: Triamcinolone Acetonide Cream; Device: Fractional Ablative Laser |
| No laser | Placebo comparator | Split person design. Each participant had a skin burn area that was treated with the laser and a skin burn area that was not treated with the laser. Receives: Drug: Lidocaine Cream; Drug: Triamcinolone Acetonide Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contracture of Scar Surface Area (Percentage of Original Area)
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.
Measured: 90 days post-grafting
Contracture of Scar Surface Area (Percentage of Original Area)
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.
Measured: 1 year post-grafting
Secondary outcomes (16)
Scar Roughness
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.
Measured: 90 days post-grafting
Scar Roughness
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.
Measured: 1 year post-grafting
Biomechanics Stiffness
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.
Measured: 90 days post-grafting
Biomechanics Stiffness
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.
Measured: 1 year post-grafting
Biomechanics Elasticity
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.
Measured: 90 days post-grafting
Biomechanics Elasticity
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.
Measured: 1 year post-grafting
Erythema Index
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. The erythema levels are measured on a scale ranging from 0 to around 999. This index reflects the redness of the skin, which can be an indicator of various skin conditions or reactions. Higher index indicates a scar that is more red.
Measured: 90 days post-grafting
Erythema Index
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. The erythema levels are measured on a scale ranging from 0 to around 999. This index reflects the redness of the skin, which can be an indicator of various skin conditions or reactions. Higher index indicates a scar that is more red.
Measured: 1 year post-grafting
Vancouver Scar Scale (VSS)
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.
Measured: 90 days post-grafting
Vancouver Scar Scale (VSS)
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.
Measured: 1 year post-grafting
Patient and Observer Scar Assessment Scale (POSAS)--Patient
Subjective scar scale for the patient that measures perception of scar height, pliability, pigmentation, vascularization, and relief. Survey consists of seven questions with total score ranging from 7-70. The higher the score the worse the scar.
Measured: 90 days post-grafting
Patient and Observer Scar Assessment Scale (POSAS)--Observer
Subjective scar scale for the observer measures perception of scar height, pliability, pigmentation, vascularization, and relief. Survey consists of six questions. Total score range 6-60. The higher the score the worse the scar.
Measured: 90 days post-grafting
Patient and Observer Scar Assessment Scale (POSAS)--Patient
Subjective scar scale for the patient that measures perception of scar height, pliability, pigmentation, vascularization, and relief. Survey consists of seven questions with total score ranging from 7-70. The higher the score the worse the scar.
Measured: 1 year post-grafting
Patient and Observer Scar Assessment Scale (POSAS)--Observer
Subjective scar scale for the observer measures perception of scar height, pliability, pigmentation, vascularization, and relief. Survey consists of six questions. Total score range 6-60. The higher the score the worse the scar.
Measured: 1 year post-grafting
Patient-Reported Satisfaction
Subjective measurement of patient satisfaction of outcome based on a 0-10 Likert scale with 10 being the best outcome.
Measured: 90 days post-grafting
Patient-Reported Satisfaction
Subjective measurement of patient satisfaction of outcome based on a 0-10 Likert scale with 10 being the best outcome.
Measured: 1 year post-grafting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start14 Dec 2020
- Primary completion29 Sep 2023
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Burn ScarStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Bailey, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176705
- Sponsor's protocol ID
- IRB00058363
- Status last verified
- Jul 2023
- First submitted
- 20 Nov 2019
- Last updated
- 29 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: We will plan to share individual participant data with other researchers. We welcome critical examination of the protocol, statistical analysis of recorded data, informed consent form, and clinical study report. We are happy to share de-identified data (original photo files, tracings, and recorded measures of skin quality) and responses to questionnaires.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Early Postoperative Fractional Ablative Laser Treatment of Skin Grafts for Burns
- ClinicalTrials.gov ID
- NCT04176705
- Acronym / sponsor ID
- IRB00058363
- Conditions
- Burn Scar, Skin Graft Scar
- Keywords
- Fractional laser, Ablative Laser, Carbon Dioxide Laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 25 Nov 2019 (actual)
- Results
- Posted 29 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This pilot study is being conducted to establish safety, however the study team will make multiple measures to measure for efficacy as well. The study team hypothesizes that human split-thickness skin grafts will safely respond similar to the porcine model when treated with the Fractional Carbon Dioxide (FxCO2) laser and have significantly less secondary contracture than control sites. The great majority of laser studies have addressed treatment of established scars. Ideally, treatment modalities could be moved into the acute period of injury, to shorten the recovery time of thermal burns by decreasing the time to maximum recovery, and mitigate scar formation. The current study will address the impact on treatment of skin graft applied in the treatment of acute burn wounds. Preliminary work completed by our team has confirmed that the red Duroc porcine model is a good model of hypertrophic scar formation in humans, and early use of the FxCO2 on split-thickness skin grafts decreased secondary contracture. Further, the study team has identified a period of 19 weeks between the time custom-made compression garments are ordered and actually applied with benefit to the patient. The study team has identified a "therapeutic donut hole" in which they have no efficacious alternative to offer until about 19 weeks. In these patients who had larger burn returning to the OR for additional procedures, the study team was able to offer FxCO2 treatment as a "salvage" therapy. With this, the study team has demonstrated safety for the skin graft and anecdotal efficacy. The study team proposes a pilot study to prospectively demonstrate safety in a controlled study and attempt to establish efficacy of early (post grafting day 7-10) FxCO2 laser treatment of split-thickness skin graft applied in the treatment of burn injuries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser | Experimental | Drug: Lidocaine Cream, Drug: Triamcinolone Acetonide Cream, Device: Fractional Ablative LaserSplit person design. Each participant had a skin burn area that was treated with the laser and a skin burn area that was not treated with the laser. |
| No laser | Placebo comparator | Drug: Lidocaine Cream, Drug: Triamcinolone Acetonide CreamSplit person design. Each participant had a skin burn area that was treated with the laser and a skin burn area that was not treated with the laser. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are to undergo skin grafting procedures for acute treatment of thermal burns.
- Patients with grafts placed over at least 100cm^2
Key exclusion criteria (2 listed)
- Patients who have are not scheduled to undergo skin grafting procedures
- Patients who have grafts placed under 100cm^2
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 |
|---|---|---|
| Lidocaine CreamBoth 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. | Drug | Laser, No laser |
| Triamcinolone Acetonide CreamTriamcinolone 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. | Drug | Laser, No laser |
| Fractional Ablative LaserApplied to only site that is randomized to laser intervention | Device | Laser |
Primary outcome
Contracture of Scar Surface Area (Percentage of Original 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.
Contracture of Scar Surface Area (Percentage of Original 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.
16 secondary outcomes
Scar Roughness
Time frame: 90 days post-grafting
Scar Roughness
Time frame: 1 year post-grafting
Biomechanics Stiffness
Time frame: 90 days post-grafting
Biomechanics Stiffness
Time frame: 1 year post-grafting
Biomechanics Elasticity
Time frame: 90 days post-grafting
Biomechanics Elasticity
Time frame: 1 year post-grafting
Erythema Index
Time frame: 90 days post-grafting
Erythema Index
Time frame: 1 year post-grafting
Vancouver Scar Scale (VSS)
Time frame: 90 days post-grafting
Vancouver Scar Scale (VSS)
Time frame: 1 year post-grafting
Patient and Observer Scar Assessment Scale (POSAS)--Patient
Time frame: 90 days post-grafting
Patient and Observer Scar Assessment Scale (POSAS)--Observer
Time frame: 90 days post-grafting
Patient and Observer Scar Assessment Scale (POSAS)--Patient
Time frame: 1 year post-grafting
Patient and Observer Scar Assessment Scale (POSAS)--Observer
Time frame: 1 year post-grafting
Patient-Reported Satisfaction
Time frame: 90 days post-grafting
Patient-Reported Satisfaction
Time frame: 1 year post-grafting
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. We will plan to share individual participant data with other researchers. We welcome critical examination of the protocol, statistical analysis of recorded data, informed consent form, and clinical study report. We are happy to share de-identified data (original photo files, tracings, and recorded measures of skin quality) and responses to questionnaires.
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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.
John Bailey, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine Cream, Triamcinolone Acetonide Cream and Fractional Ablative Laser in people with Burn Scar and Skin Graft Scar, run by Wake Forest University Health Sciences at 1 site in United States.
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 2 inclusion and 2 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 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 29 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Contracture of Scar Surface Area (Percentage of Original Area) (time frame: 90 days post-grafting). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2024.