Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine Cream | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 1 year post-grafting |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John Bailey, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
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.
Data will become available within 6 months of data completion.
Research groups with authors who have at least one related publication
Not provided
Each of the nine subjects had two burned areas. One area was treated with laser and the other area was not treated.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Laser | Lidocaine Cream: 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: 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 Laser: Applied to only site that is randomized to laser intervention |
| FG001 | No Laser | Lidocaine Cream: 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: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of nine subjects were enrolled. Each of the nine subjects had two burned areas. Each had one area treated with laser and the other area was not treated.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall Participants | This is a split person design. Overall participants in both arms are included here. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | One subject withdrew after signing consent. | Posted | Mean | Standard Deviation | percentage | 90 days post-grafting | skin burn area | skin burn area |
|
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Laser | Lidocaine Cream: 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: 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 Laser: Applied to only site that is randomized to laser intervention |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | Cardiac disorders | Systematic Assessment | cardiovascular embarrassment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Bailey, MD | Wake Forest University Health Sciences | (336) 716-8002 | jkbailey@wakehealth.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 30, 2020 | Oct 1, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 9, 2023 | Nov 1, 2023 | ICF_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Triamcinolone Acetonide Cream | Drug | 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 Laser | Device | Applied to only site that is randomized to laser intervention |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 1 year post-grafting |
| Lost to Follow-up |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | No Laser | Split person design. Lidocaine Cream: 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: 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. |
|
|
| Primary | 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. | Posted | Number | percentage | 1 year post-grafting | skin burn area | skin burn area |
|
|
|
| Secondary | 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. | Data could not be collected. Unable to acquire molding due to COVID supply chain challenges. | Posted | 90 days post-grafting | skin burn area | skin burn area |
|
|
| Secondary | 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. | Data could not be collected. Unable to acquire molding due to COVID supply chain challenges. | Posted | 1 year post-grafting | skin burn area | skin burn area |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | kPa | 90 days post-grafting | skin burn area | skin burn area |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | kPa | 1 year post-grafting | skin burn area | skin burn area |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | millimeters | 90 days post-grafting | skin burn area | skin burn area |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | millimeters | 1 year post-grafting | skin burn area | skin burn area |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 90 days post-grafting | skin burn area | skin burn area |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 1 year post-grafting | skin burn area | skin burn area |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 90 days post-grafting | skin burn area | skin burn area |
|
|
|
| Secondary | 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. | Posted | Number | score on a scale | 1 year post-grafting | skin burn area | skin burn area |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 90 days post-grafting | skin burn area | skin burn area |
|
|
|
| Secondary | 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. | Posted | Number | score on a scale | 90 days post-grafting | skin burn area | skin burn area |
|
|
|
| Secondary | 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. | Posted | Number | score on a scale | 1 year post-grafting | skin burn area | skin burn area |
|
|
|
| Secondary | 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. | Posted | Number | score on a scale | 1 year post-grafting | skin burn area | skin burn area |
|
|
|
| Secondary | Patient-Reported Satisfaction | Subjective measurement of patient satisfaction of outcome based on a 0-10 Likert scale with 10 being the best outcome. | Posted | Mean | Standard Deviation | score on a scale | 90 days post-grafting | skin burn area | skin burn area |
|
|
|
| Secondary | Patient-Reported Satisfaction | Subjective measurement of patient satisfaction of outcome based on a 0-10 Likert scale with 10 being the best outcome. | Posted | Number | score on a scale | 1 year post-grafting | skin burn area | skin burn area |
|
|
|
| 1 |
| 9 |
| 1 |
| 9 |
| 0 |
| 9 |
| EG001 | No Laser | Lidocaine Cream: 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: 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. | 1 | 9 | 1 | 9 | 0 | 9 |
Not provided
Not provided