6 Participants Needed

Laser Therapy for Burn Scars

JG
Overseen ByJustin Gawaziuk, MSc
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Manitoba
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment for burn scars?

Research shows that fractional CO2 laser therapy significantly improves burn scars by reducing scar firmness and improving surface texture, with noticeable results after just one treatment session. Patients also report high satisfaction with the treatment, indicating its effectiveness in improving the appearance and quality of life for those with burn scars.12345

Is laser therapy safe for treating burn scars?

Laser therapy, specifically Fractional CO2 Laser, is generally safe for treating burn scars, with minimal adverse events reported. In a study of 544 treatments, only 2.4% experienced minor issues like increased pain, numbness, redness, or blistering, and most patients saw improvements in their scars.45678

How is Fractional Vascular Laser Therapy different from other treatments for burn scars?

Fractional Vascular Laser Therapy, specifically using a Fractional CO2 Laser, is unique because it offers pronounced clinical outcomes with fewer treatment sessions compared to nonablative lasers. It works by creating controlled thermal damage, which helps remodel the scar tissue and improve its appearance, making it a novel option for treating burn scars.345910

What is the purpose of this trial?

While the literature tends to support the use of laser therapy in the management of burn scars, there is a definite lack of appropriately powered, randomized controlled trials. Laser therapy can be quite expensive when compared to other treatment modalities for burn scars, and while promising, its true usefulness has yet to be conclusively demonstrated. For this reason, our assessing the effects of fractional vascular lasers on burn scars. It has been hypothesized that the fractional vascular lasers work on mature scars to decrease scar formation, and the fractional laser works on scar that is quiescent to promote remodelling. The retexturing/ resurfacing of the laser theoretically can decrease the visibility of the mesh pattern created by meshed split thickness skin graft).Objective:To determine the benefit of fractional vascular laser treatment in improving burn scar height, texture, vascularity and pliability in late burn scars.

Research Team

SL

S Logsetty, MD

Principal Investigator

University of Manitoba

Eligibility Criteria

This trial is for individuals with burn scars that are 6-12 months old, located on the trunk or limbs. Participants should have a Fitzpatrick skin type I-III and must live in Winnipeg. People with open wounds cannot participate.

Inclusion Criteria

Thermal burn scar on trunk or extremities
Fitzpatrick skin type I-III
Living in Winnipeg
See 1 more

Exclusion Criteria

I have an open wound.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive fractional vascular laser treatment to improve burn scar height, texture, vascularity, and pliability

15 weeks
5 visits (every 3 weeks)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Fractional Vascular Laser
Trial Overview The study is testing fractional vascular laser therapy to see if it can improve the height, texture, vascularity, and pliability of mature burn scars. It's a randomized controlled trial aiming to provide conclusive evidence about the effectiveness of this expensive treatment.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: DistalExperimental Treatment1 Intervention
location of scar distal to heart
Group II: ProximalActive Control1 Intervention
location of the scar proximal to heart

Fractional Vascular Laser is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Fractional CO2 Laser for:
  • Burn scars
  • Hypertrophic scars
  • Keloid scars
🇪🇺
Approved in European Union as Fractional Ablative Laser for:
  • Burn scars
  • Hypertrophic scars
  • Atrophic scars
🇨🇦
Approved in Canada as Fractional Vascular Laser Therapy for:
  • Burn scars
  • Late burn scars
  • Mature scars

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials
628
Recruited
209,000+

Findings from Research

Fractional ablative carbon dioxide laser therapy is a safe and effective treatment for hypertrophic burn scars, showing significant improvements in scar appearance and quality of life after just one session in a study of 10 patients.
After 6 months, patients experienced notable reductions in scar firmness and surface relief, with improvements measured by various clinical scales, indicating that while more sessions may be needed for optimal results, even a single treatment can lead to meaningful changes.
Ultrapulsed fractional ablative carbon dioxide laser treatment of hypertrophic burn scars: evaluation of an in-patient controlled, standardized treatment approach.Poetschke, J., Dornseifer, U., Clementoni, MT., et al.[2019]
A survey of 64 burn patients treated with the Erbium-Yag laser showed that 94% reported some degree of improvement in their scars, with an average satisfaction score of 8.3 out of 10.
The treatment significantly reduced symptoms associated with scars, such as pain and itching, indicating that fractional laser therapy is an effective option for improving burn scar characteristics.
Patient satisfaction after fractional ablation of burn scar with 2940nm wavelength Erbium-Yag laser.Madni, TD., Nakonezny, PA., Imran, JB., et al.[2022]
A multicenter study involving 29 subjects with hypertrophic burn scars demonstrated that fractional ablative CO2 laser treatment significantly improved the elasticity, thickness, and overall appearance of scars, with objective measures showing improvements at a statistically significant level (P < 0.01).
Patient-reported outcomes also indicated significant reductions in pain and pruritus, and these improvements were sustained for at least 6 months after the treatment, highlighting the efficacy and lasting benefits of this laser therapy.
Fractional Ablative Laser Therapy is an Effective Treatment for Hypertrophic Burn Scars: A Prospective Study of Objective and Subjective Outcomes.Miletta, N., Siwy, K., Hivnor, C., et al.[2022]

References

Ultrapulsed fractional ablative carbon dioxide laser treatment of hypertrophic burn scars: evaluation of an in-patient controlled, standardized treatment approach. [2019]
Patient satisfaction after fractional ablation of burn scar with 2940nm wavelength Erbium-Yag laser. [2022]
Fractional Ablative Laser Therapy is an Effective Treatment for Hypertrophic Burn Scars: A Prospective Study of Objective and Subjective Outcomes. [2022]
Efficacy of fractional CO2 laser in combination with stromal vascular fraction (SVF) compared with fractional CO2 laser alone in the treatment of burn scars: a randomized controlled clinical trial. [2023]
Dermal Remodeling of Burn Scar by Fractional CO2 Laser. [2017]
Hypertrophic Scar Improvement by Early Intervention With Ablative Fractional Carbon Dioxide Laser Treatment. [2021]
Treatment of Hypertrophic Burn Scars With Laser Therapy: A Review of Adverse Events. [2023]
Fractional Carbon Dioxide Laser in Patients with Skin Phototypes III to VI and Facial Burn Sequelae: 1-Year Follow-Up. [2021]
New Developments for Fractional Co2 Resurfacing for Skin Rejuvenation and Scar Reduction. [2020]
Efficacy of fractional carbon dioxide laser therapy for burn scars: a meta-analysis. [2022]
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