N/A
N=18
Fractional Ablative Laser Treatment for Skin Grafts
Burn Scar · Skin Graft Scar
Bottom Line
View on ClinicalTrials.gov: NCT04176705 ↗Enrolled (actual)
18
Serious AEs
11.1%
Results posted
Nov 2024
Primary outcome: Primary: Contracture of Scar Surface Area (Percentage of Original Area) — 97; 97 percentage
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lidocaine Cream (Drug); Triamcinolone Acetonide Cream (Drug); Fractional Ablative Laser (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Contracture of Scar Surface Area (Percentage of Original Area) |
106; 102 | — |
| PRIMARY Contracture of Scar Surface Area (Percentage of Original Area) |
106; 102 | — |
| SECONDARY Scar Roughness |
— | — |
| SECONDARY Scar Roughness |
— | — |
| SECONDARY Biomechanics Stiffness |
283; 301 | — |
| SECONDARY Biomechanics Stiffness |
283; 301 | — |
| SECONDARY Biomechanics Elasticity |
0.71; 0.71 | — |
| SECONDARY Biomechanics Elasticity |
0.71; 0.71 | — |
| SECONDARY Erythema Index |
425; 384 | — |
| SECONDARY Erythema Index |
425; 384 | — |
| SECONDARY Vancouver Scar Scale (VSS) |
5; 5 | — |
| SECONDARY Vancouver Scar Scale (VSS) |
5; 5 | — |
| SECONDARY Patient and Observer Scar Assessment Scale (POSAS)--Patient |
19; 19 | — |
| SECONDARY Patient and Observer Scar Assessment Scale (POSAS)--Observer |
13; 14 | — |
| SECONDARY Patient and Observer Scar Assessment Scale (POSAS)--Patient |
19; 19 | — |
| SECONDARY Patient and Observer Scar Assessment Scale (POSAS)--Observer |
13; 14 | — |
| SECONDARY Patient-Reported Satisfaction |
3; 3 | — |
| SECONDARY Patient-Reported Satisfaction |
3; 3 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04176705). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.