Burn Scar, Skin Graft Scar
Conditions
Keywords
Fractional laser, Ablative Laser, Carbon Dioxide Laser
Brief 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. 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.
Interventions
DRUGLidocaine 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 (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
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are to undergo skin grafting procedures for acute 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contracture of Scar Surface Area (Percentage of Original Area) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biomechanics Stiffness | 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. |
| Biomechanics Elasticity | 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. |
| Erythema Index | 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. 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. |
| Scar Roughness | 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. |
| Patient and Observer Scar Assessment Scale (POSAS)--Patient | 90 days post-grafting | 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. |
| Patient and Observer Scar Assessment Scale (POSAS)--Observer | 90 days post-grafting | 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. |
| Patient-Reported Satisfaction | 90 days post-grafting | Subjective measurement of patient satisfaction of outcome based on a 0-10 Likert scale with 10 being the best outcome. |
| Vancouver Scar Scale (VSS) | 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. |
Countries
United States
Participant flow
Pre-assignment details
Each of the nine subjects had two burned areas. One area was treated with laser and the other area was not treated.
Participants by arm
| Arm | Count |
|---|---|
| Overall Participants This is a split person design. Overall participants in both arms are included here. | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
| Overall Study | Lost to Follow-up | 3 | 3 |
| Overall Study | Withdrawal by Subject | 4 | 4 |
Baseline characteristics
| Characteristic | Overall Participants |
|---|---|
| Age, Continuous | 51 years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 9 | 1 / 9 |
| other Total, other adverse events | 0 / 9 | 0 / 9 |
| serious Total, serious adverse events | 1 / 9 | 1 / 9 |
Outcome results
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.
Time frame: 1 year post-grafting
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Laser | Contracture of Scar Surface Area (Percentage of Original Area) | 106 percentage |
| No Laser | Contracture of Scar Surface Area (Percentage of Original Area) | 102 percentage |
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.
Time frame: 90 days post-grafting
Population: One subject withdrew after signing consent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laser | Contracture of Scar Surface Area (Percentage of Original Area) | 97 percentage | Standard Deviation 14 |
| No Laser | Contracture of Scar Surface Area (Percentage of Original Area) | 97 percentage | Standard Deviation 14 |
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.
Time frame: 90 days post-grafting
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laser | Biomechanics Elasticity | 0.87 millimeters | Standard Deviation 0.52 |
| No Laser | Biomechanics Elasticity | 0.66 millimeters | Standard Deviation 0.31 |
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.
Time frame: 1 year post-grafting
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laser | Biomechanics Elasticity | 0.71 millimeters | Standard Deviation 0.28 |
| No Laser | Biomechanics Elasticity | 0.71 millimeters | Standard Deviation 0.28 |
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.
Time frame: 90 days post-grafting
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laser | Biomechanics Stiffness | 206 kPa | Standard Deviation 143 |
| No Laser | Biomechanics Stiffness | 231 kPa | Standard Deviation 187 |
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.
Time frame: 1 year post-grafting
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laser | Biomechanics Stiffness | 283 kPa | Standard Deviation 69 |
| No Laser | Biomechanics Stiffness | 301 kPa | Standard Deviation 48 |
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.
Time frame: 1 year post-grafting
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laser | Erythema Index | 425 score on a scale | Standard Deviation 35 |
| No Laser | Erythema Index | 384 score on a scale | Standard Deviation 34 |
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.
Time frame: 90 days post-grafting
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laser | Erythema Index | 379 score on a scale | Standard Deviation 117 |
| No Laser | Erythema Index | 360 score on a scale | Standard Deviation 101 |
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.
Time frame: 1 year post-grafting
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Laser | Patient and Observer Scar Assessment Scale (POSAS)--Observer | 13 score on a scale |
| No Laser | Patient and Observer Scar Assessment Scale (POSAS)--Observer | 14 score on a scale |
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.
Time frame: 90 days post-grafting
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Laser | Patient and Observer Scar Assessment Scale (POSAS)--Observer | 19 score on a scale |
| No Laser | Patient and Observer Scar Assessment Scale (POSAS)--Observer | 18 score on a scale |
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.
Time frame: 90 days post-grafting
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laser | Patient and Observer Scar Assessment Scale (POSAS)--Patient | 32 score on a scale | Standard Deviation 5.4 |
| No Laser | Patient and Observer Scar Assessment Scale (POSAS)--Patient | 36 score on a scale | Standard Deviation 16 |
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.
Time frame: 1 year post-grafting
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Laser | Patient and Observer Scar Assessment Scale (POSAS)--Patient | 19 score on a scale |
| No Laser | Patient and Observer Scar Assessment Scale (POSAS)--Patient | 19 score on a scale |
Secondary
Patient-Reported Satisfaction
Subjective measurement of patient satisfaction of outcome based on a 0-10 Likert scale with 10 being the best outcome.
Time frame: 1 year post-grafting
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Laser | Patient-Reported Satisfaction | 3 score on a scale |
| No Laser | Patient-Reported Satisfaction | 3 score on a scale |
Secondary
Patient-Reported Satisfaction
Subjective measurement of patient satisfaction of outcome based on a 0-10 Likert scale with 10 being the best outcome.
Time frame: 90 days post-grafting
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laser | Patient-Reported Satisfaction | 5.25 score on a scale | Standard Deviation 1.5 |
| No Laser | Patient-Reported Satisfaction | 5.75 score on a scale | Standard Deviation 1.89 |
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.
Time frame: 90 days post-grafting
Population: Data could not be collected. Unable to acquire molding due to COVID supply chain challenges.
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.
Time frame: 1 year post-grafting
Population: Data could not be collected. Unable to acquire molding due to COVID supply chain challenges.
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.
Time frame: 90 days post-grafting
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laser | Vancouver Scar Scale (VSS) | 4.7 score on a scale | Standard Deviation 1 |
| No Laser | Vancouver Scar Scale (VSS) | 4.7 score on a scale | Standard Deviation 1 |
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.
Time frame: 1 year post-grafting
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Laser | Vancouver Scar Scale (VSS) | 5 score on a scale |
| No Laser | Vancouver Scar Scale (VSS) | 5 score on a scale |