Trial Outcomes & Findings for Fractional Ablative Laser Treatment for Skin Grafts (NCT NCT04176705)

NCT ID: NCT04176705

Last Updated: 2024-11-29

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 9 participants
• Primary outcome timeframe: 90 days post-grafting
• Results posted on: 2024-11-29

Participant Flow

Each of the nine subjects had two burned areas. One area was treated with laser and the other area was not treated.

Unit of analysis: skin burn areas

Participant milestones

Measure	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	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.
Overall Study STARTED	9 9	9 9
Overall Study COMPLETED	1 1	1 1
Overall Study NOT COMPLETED	8 8	8 8

Reasons for withdrawal

Measure	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	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.
Overall Study Withdrawal by Subject	4	4
Overall Study Death	1	1
Overall Study Lost to Follow-up	3	3

Baseline Characteristics

Fractional Ablative Laser Treatment for Skin Grafts

Baseline characteristics by cohort

Measure	Overall Participants n=9 Participants This is a split person design. Overall participants in both arms are included here.
Age, Continuous	51 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days post-grafting

Population: One subject withdrew after signing consent.

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.

Outcome measures

Measure	Laser n=8 skin burn area 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. Fractional Ablative Laser: Applied to only site that is randomized to laser intervention	No Laser n=8 skin burn area 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.
Contracture of Scar Surface Area (Percentage of Original Area)	97 percentage Standard Deviation 14	97 percentage Standard Deviation 14

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Laser n=1 skin burn area 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. Fractional Ablative Laser: Applied to only site that is randomized to laser intervention	No Laser n=1 skin burn area 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.
Contracture of Scar Surface Area (Percentage of Original Area)	106 percentage	102 percentage

SECONDARY outcome

Timeframe: 90 days post-grafting

Population: Data could not be collected. Unable to acquire molding due to COVID supply chain challenges.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year post-grafting

Population: Data could not be collected. Unable to acquire molding due to COVID supply chain challenges.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Laser n=8 skin burn area 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. Fractional Ablative Laser: Applied to only site that is randomized to laser intervention	No Laser n=8 skin burn area 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.
Biomechanics Stiffness	206 kPa Standard Deviation 143	231 kPa Standard Deviation 187

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Laser n=1 skin burn area 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. Fractional Ablative Laser: Applied to only site that is randomized to laser intervention	No Laser n=1 skin burn area 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.
Biomechanics Stiffness	283 kPa Standard Deviation 69	301 kPa Standard Deviation 48

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Laser n=8 skin burn area 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. Fractional Ablative Laser: Applied to only site that is randomized to laser intervention	No Laser n=8 skin burn area 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.
Biomechanics Elasticity	0.87 millimeters Standard Deviation 0.52	0.66 millimeters Standard Deviation 0.31

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Laser n=1 skin burn area 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. Fractional Ablative Laser: Applied to only site that is randomized to laser intervention	No Laser n=1 skin burn area 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.
Biomechanics Elasticity	0.71 millimeters Standard Deviation 0.28	0.71 millimeters Standard Deviation 0.28

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Laser n=8 skin burn area 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. Fractional Ablative Laser: Applied to only site that is randomized to laser intervention	No Laser n=9 skin burn area 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.
Erythema Index	379 score on a scale Standard Deviation 117	360 score on a scale Standard Deviation 101

SECONDARY outcome

Timeframe: 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. 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.

Outcome measures

Measure	Laser n=1 skin burn area 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. Fractional Ablative Laser: Applied to only site that is randomized to laser intervention	No Laser n=1 skin burn area 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.
Erythema Index	425 score on a scale Standard Deviation 35	384 score on a scale Standard Deviation 34

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Laser n=4 skin burn area 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. Fractional Ablative Laser: Applied to only site that is randomized to laser intervention	No Laser n=4 skin burn area 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.
Vancouver Scar Scale (VSS)	4.7 score on a scale Standard Deviation 1.0	4.7 score on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Laser n=1 skin burn area 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. Fractional Ablative Laser: Applied to only site that is randomized to laser intervention	No Laser n=1 skin burn area 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.
Vancouver Scar Scale (VSS)	5 score on a scale	5 score on a scale

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Laser n=8 skin burn area 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. Fractional Ablative Laser: Applied to only site that is randomized to laser intervention	No Laser n=8 skin burn area 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.
Patient and Observer Scar Assessment Scale (POSAS)--Patient	32 score on a scale Standard Deviation 5.4	36 score on a scale Standard Deviation 16

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Laser n=1 skin burn area 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. Fractional Ablative Laser: Applied to only site that is randomized to laser intervention	No Laser n=1 skin burn area 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.
Patient and Observer Scar Assessment Scale (POSAS)--Observer	19 score on a scale	18 score on a scale

SECONDARY outcome

Timeframe: 1 year 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.

Outcome measures

Measure	Laser n=1 skin burn area 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. Fractional Ablative Laser: Applied to only site that is randomized to laser intervention	No Laser n=1 skin burn area 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.
Patient and Observer Scar Assessment Scale (POSAS)--Patient	19 score on a scale	19 score on a scale

SECONDARY outcome

Timeframe: 1 year 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.

Outcome measures

Measure	Laser n=1 skin burn area 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. Fractional Ablative Laser: Applied to only site that is randomized to laser intervention	No Laser n=1 skin burn area 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.
Patient and Observer Scar Assessment Scale (POSAS)--Observer	13 score on a scale	14 score on a scale

SECONDARY outcome

Timeframe: 90 days post-grafting

Subjective measurement of patient satisfaction of outcome based on a 0-10 Likert scale with 10 being the best outcome.

Outcome measures

Measure	Laser n=8 skin burn area 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. Fractional Ablative Laser: Applied to only site that is randomized to laser intervention	No Laser n=8 skin burn area 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.
Patient-Reported Satisfaction	5.25 score on a scale Standard Deviation 1.5	5.75 score on a scale Standard Deviation 1.89

SECONDARY outcome

Timeframe: 1 year post-grafting

Subjective measurement of patient satisfaction of outcome based on a 0-10 Likert scale with 10 being the best outcome.

Outcome measures

Measure	Laser n=1 skin burn area 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. Fractional Ablative Laser: Applied to only site that is randomized to laser intervention	No Laser n=1 skin burn area 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.
Patient-Reported Satisfaction	3 score on a scale	3 score on a scale

Adverse Events

Laser

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

No Laser

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Laser n=9 participants at risk 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	No Laser n=9 participants at risk 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.
Cardiac disorders death	11.1% 1/9 • Number of events 1 • 1 year	11.1% 1/9 • Number of events 1 • 1 year

Other adverse events

Adverse event data not reported

Additional Information

John Bailey, MD

Wake Forest University Health Sciences

Phone: (336) 716-8002

Email: jkbailey@wakehealth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place