Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Manitoba
Disqualifiers: Open wound
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
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.
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.
12345Is 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.
23678How 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.
123910Eligibility 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
+1 more
Exclusion Criteria
I have an open wound.
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
University of ManitobaWinnipeg, Canada
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Who Is Running the Clinical Trial?
University of ManitobaLead Sponsor
References
Fractional Ablative Laser Therapy is an Effective Treatment for Hypertrophic Burn Scars: A Prospective Study of Objective and Subjective Outcomes. [2022]The aim of this study is to determine objective and subjective changes in mature hypertrophic burn scars treated with a fractional ablative carbon dioxide (CO2) laser.
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]Label="BACKGROUND">The appearance of skin scars is known as one of the main side effects of skin burns. Stromal vascular fraction (SVF), as a rich source of cell populations with tissue regeneration properties, plays an important role in the healing of skin lesions. Fractional CO2 lasers have occupied a special place in treating skin lesions, particularly skin scars, since their introduction. Our study aimed to compare the combination of SVF and fractional CO2 laser with fractional CO2 laser alone in the treatment of burn scars.
Dermal Remodeling of Burn Scar by Fractional CO2 Laser. [2017]Ablative CO2 fractional lasers have recently been introduced for burn scar treatment because of pronounced clinical outcomes with fewer treatment sessions than nonablative fractional laser.
Ultrapulsed fractional ablative carbon dioxide laser treatment of hypertrophic burn scars: evaluation of an in-patient controlled, standardized treatment approach. [2019]In this study, we aimed to quantify the effects of fractional ablative carbon dioxide laser therapy in the treatment of widespread hypertrophic burn scars. While many different pilot studies have described the potential of the technology and expert groups and current guidelines, alike, recommend its use, the level of evidence for the efficacy of fractional CO2-laser treatment for burn scars is currently very low. Ten patients (three male, seven female) with hypertrophic burn scars were treated with a single course of fractional CO2-laser therapy in an in-patient controlled setup, using a standardized treatment paradigm. Documentation was based on modern scar scales and questionnaires, like the Vancouver Scar Scale (VSS), Patient and Observer Scar Assessment Scale (POSAS), and Dermatology Life Quality Index (DLQI), as well as state of the art clinical measurements (PRIMOS, Cutometer). Over the course of 6 months after treatment, VSS and POSAS scores showed significant improvement in the rating of scar parameters, as did the quality of life rating according to the DLQI. In the treated scars, surface relief improved significantly, as S max decreased by 1893 μm (-36.92%) (p = 0.0273) and S z by 1615 μm (-36.37%) (p = 0.0488). Scar firmness in treated scars could be reduced by 30% after one treatment session, as R 0 improved by 0.0797 mm (+30.38%) (p = 0.0212). Fractional ablative CO2-laser treatment is a safe and efficacious option for the treatment of hypertrophic burn scars. While more treatment sessions are required for satisfying results, significant improvement is already apparent after a single course of treatment.
Patient satisfaction after fractional ablation of burn scar with 2940nm wavelength Erbium-Yag laser. [2022]Fractional laser therapy is a new treatment with potential benefit in the treatment of burn scars. We sought to determine patient satisfaction after burn scar treatment with the Erbium-Yag laser.
Treatment of Hypertrophic Burn Scars With Laser Therapy: A Review of Adverse Events. [2023]Hypertrophic scarring, characterized by excessive scar tissue formation, is a debilitating outcome that significantly impairs physical and psychosocial recovery after burn injury. Hypertrophic scarring affects a substantial proportion of burn survivors, with reported prevalence as high as 70%. Fractional CO 2 laser (FCL) therapy, a therapy commonly used in acne scar treatment or skin rejuvenation, has become popular in treating hypertrophic scars. Little is known regarding FCL's adverse events for burn scar treatment. We hypothesize that FCL is a safe treatment modality with minimal adverse events in the management of hypertrophic burn scars. This is a retrospective chart review of adverse events after FCL at 2 centers within a single institution. Burn patients undergoing FCL between May 1, 2019, and June 1, 2021 were included. Demographics, injury etiology, laser treatment details, and adverse events were collected. A total of 170 patients, 77 (45.3%) males and 93 (54.7%) females, underwent 544 FCL therapies for burn scars. The average number of treatments per patient was 3 ± 2.23, with a range of 1 to 17 sessions. From the total 544 laser therapy sessions, 13 adverse events (2.4%) were reported. There were 5 reports (0.9%) of increased postprocedural pain and 1 report (0.2%) of increased paresthesia/numbness to laser site. Three instances (0.6%) of increased erythema and 4 reports (0.7%) of epidermal sloughing or blistering were reported. All but 5 patients (2.9%) reported improvements to scar symptoms. This study demonstrates minimal adverse events associated with FCL for hypertrophic burn scar treatment.
Hypertrophic Scar Improvement by Early Intervention With Ablative Fractional Carbon Dioxide Laser Treatment. [2021]Label="BACKGROUND AND OBJECTIVES">Ablative fractional laser treatment has been used to improve the color and texture of hypertrophic scars with safe and effective results. However, no consensus on the optimal time to initiate fractional laser treatment is available. The effect on early-stage scars remains controversial. This study was designed to assess the efficacy and safety of ablative fractional carbon dioxide (CO2 ) laser treatments for hypertrophic burn scars and to analyze the efficacy and safety in the early period within 3 months after injury.
Fractional Carbon Dioxide Laser in Patients with Skin Phototypes III to VI and Facial Burn Sequelae: 1-Year Follow-Up. [2021]Fractional carbon dioxide laser treatment in postburn scars is safe and effective, but high rates of hypochromia (35 percent) have been described in patients with skin phototypes V and VI after 2 months. The authors evaluated the efficacy and safety of fractional carbon dioxide laser treatment of burn scars in skin phototypes III to VI after 1 year, focusing on the incidence of hypochromia.
New Developments for Fractional Co2 Resurfacing for Skin Rejuvenation and Scar Reduction. [2020]Fractional CO2 procedures are an established, safe and effective armamentarium for managing skin rejuvenation and scarring. Very short-pulse-duration devices offer a very high ablated volume/ablated surface ratio, inducing a controlled thermal damage. With this kind of device, each procedure can be customized on the features of the skin of each patient. The same device can be used to treat severe burn scars. With a very deep fractional procedure on a scar tissue, immediate relaxation of the tension and retraction forces may be obtained, and downstream, improvements are related more to the activation of a molecular cascade. The authors review the state-of-the-art, in the use of fractioned CO2 laser technology for aesthetic and scar remodelling indications.
Efficacy of fractional carbon dioxide laser therapy for burn scars: a meta-analysis. [2022]Label="BACKGROUND" NlmCategory="BACKGROUND">The present study evaluates the effectiveness of fractional carbon dioxide (CO2) laser for the treatment of burn scars.