NCT04176705

Fractional Ablative Laser Treatment for Skin Grafts

Completed NA Results posted Last updated 29 November 2024

What this trial tests

NA trial testing Lidocaine Cream in Burn Scar in 9 participants. Completed in 29 September 2023.

Timeline

14 December 2020

Primary endpoint
29 September 2023

29 September 2023

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	14 December 2020
Primary completion	29 September 2023
Estimated completion	29 September 2023
Sites	1 location across United States

Drugs / interventions tested

• Lidocaine Cream
• Triamcinolone Acetonide Cream
• Fractional Ablative Laser

Conditions studied

• Burn Scar — all drugs for Burn Scar →
• Skin Graft Scar — all drugs for Skin Graft Scar →

Sponsor

Wake Forest University Health Sciences

Who can join

18 and older, any sex, with Burn Scar or Skin Graft Scar. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Contracture of Scar Surface Area (Percentage of Original Area) Primary · 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.

Group	Value	95% CI
Laser	97	± 14
No Laser	97	± 14

Contracture of Scar Surface Area (Percentage of Original Area) Primary · 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.

Group	Value	95% CI
Laser	106
No Laser	102

Biomechanics Stiffness Secondary · 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.

Group	Value	95% CI
Laser	206	± 143
No Laser	231	± 187

Biomechanics Stiffness Secondary · 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.

Group	Value	95% CI
Laser	283	± 69
No Laser	301	± 48

Biomechanics Elasticity Secondary · 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.

Group	Value	95% CI
Laser	0.87	± 0.52
No Laser	0.66	± 0.31

Biomechanics Elasticity Secondary · 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.

Group	Value	95% CI
Laser	0.71	± 0.28
No Laser	0.71	± 0.28

Erythema Index Secondary · 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.

Group	Value	95% CI
Laser	379	± 117
No Laser	360	± 101

Erythema Index Secondary · 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.

Group	Value	95% CI
Laser	425	± 35
No Laser	384	± 34

Vancouver Scar Scale (VSS) Secondary · 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.

Group	Value	95% CI
Laser	4.7	± 1.0
No Laser	4.7	± 1.0

Vancouver Scar Scale (VSS) Secondary · 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.

Group	Value	95% CI
Laser	5
No Laser	5

Patient and Observer Scar Assessment Scale (POSAS)--Patient Secondary · 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.

Group	Value	95% CI
Laser	32	± 5.4
No Laser	36	± 16

Patient and Observer Scar Assessment Scale (POSAS)--Observer Secondary · 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.

Group	Value	95% CI
Laser	19
No Laser	18

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Laser

Serious: 1/9 (11%)

Deaths: 1/9

No Laser

Serious: 1/9 (11%)

Deaths: 1/9

Serious adverse events (1 terms)

Reaction	System	Laser	No Laser
death	Cardiac disorders	—	—

Most-reported serious reactions: death.

Data from ClinicalTrials.gov NCT04176705 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.