CO2 Laser Treatment for Burn Scars

Not currently recruiting at 1 trial location

Overseen By Melissa M McLawhorn

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medstar Health Research Institute

Must not be taking: Oral retinoids

Disqualifiers: Pregnancy, Ehlers-Danlos, AIDS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of fractional CO2 laser treatment in reducing scars from burn wounds. It targets scars from burns that healed naturally or were treated with skin grafts. Participants will receive either standard care or standard care combined with laser therapy on their scars. Ideal candidates are adults who have had a significant burn treated with a skin graft and have a donor site available for treatment. The goal is to determine if adding laser therapy improves healing and reduces scarring compared to standard treatments alone. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future burn scar treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used oral retinoid medications in the past 6 months.

What prior data suggests that this CO2 laser treatment is safe for burn scars?

Research has shown that fractional CO2 laser therapy is safe for treating burn scars. Studies have found that this treatment not only improves the appearance of scars but is also well-tolerated by patients. For example, one study found that patients experienced fewer side effects and significant improvements in their scars after using this laser treatment. Another study demonstrated that this therapy effectively thinned scars and reduced symptoms, enhancing the quality of life for individuals with burn scars. Overall, fractional CO2 laser therapy appears to be a safe option for managing burn scars. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for burn scars, which often includes topical treatments and surgery, fractional CO2 laser therapy offers a unique approach by precisely targeting the scar tissue with laser energy. This method stimulates the skin's natural healing process and promotes collagen production, leading to improved skin texture and appearance. Researchers are excited about this treatment because it has the potential to deliver more effective and faster results, with fewer side effects compared to traditional methods.

What evidence suggests that fractional CO2 laser treatment might be effective for burn scars?

Research has shown that fractional CO2 laser therapy, which participants in this trial may receive, holds promise for treating burn scars. Studies have found that it improves the appearance, movement, and symptoms of thickened burn scars. A detailed review found that this laser treatment effectively reduces the severity of burn scars. Starting this therapy early, particularly within the first six months, leads to better results. Overall, fractional CO2 laser therapy has consistently demonstrated positive outcomes in both controlled studies and real-world use. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

Adults over 18 with second or third degree burn wounds treated with skin grafts can join this trial. They must have a donor site scar of at least 4x4 inches and be able to visit the clinic for treatments and check-ups. Those with recent infections, pregnancy, nursing, certain medical conditions like Ehlers-Danlos syndrome or AIDS, recent oral retinoid use, or poor nutrition affecting healing cannot participate.

Inclusion Criteria

At least 1 second or third degree burn wound that required treatment with split-thickness skin grafts

Donor site with at least a 4 x 4 inch surface area

Able to return to clinical site for treatments and assessments of burn injuries

Exclusion Criteria

Wounds complicated by clinically significant infection within past 30 days

You are pregnant or breastfeeding.

You have a medical history of Ehlers-Danlos syndrome or AIDS.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard fractional ablative CO2 treatments to their scars and are randomized to either standard of care or standard of care plus CO2 laser therapy

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments completed 2 months ± 2 weeks after the final laser treatment

8-12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fractional CO2 Laser

Trial Overview The trial is testing fractional CO2 laser therapy on scars from burns that were left to heal naturally or treated with skin grafts. Half of each patient's donor site will receive standard care while the other half gets standard care plus laser treatment. The effects on scars will be observed and compared.

How Is the Trial Designed?

Group I: Factional CO2 Experimental Treatment 1 Intervention

Scar section receives fractional CO2 laser therapy.

Group II: Standard of Care Active Control 1 Intervention

Scar section does not receive CO2 laser therapy.

Who Is Running the Clinical Trial?

Medstar Health Research Institute

Lead Sponsor

Trials

202

Recruited

187,000+

Published Research Related to This Trial

Ablative carbon dioxide fractional laser treatment applied 2 to 3 weeks after thyroid surgery significantly improved the appearance of scars, as indicated by lower Vancouver Scar Scale scores in 23 women.

The treatment was found to be both effective and safe, with 12 out of 23 participants showing over 51% clinical improvement in scar appearance three months post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early postoperative treatment of thyroidectomy scars using a fractional carbon dioxide laser. Jung, JY., Jeong, JJ., Roh, HJ., et al.[2022]

Fractional CO2 laser treatment significantly improves burn scars, as evidenced by reductions in scores on various scar assessment scales, including the Vancouver Scar Scale and the Patient and Observer Scar Assessment Scale, across 14 studies.

The therapy not only enhances the appearance of scars by improving pigmentation, vascularity, pliability, and height, but also alleviates associated symptoms like pain and itching, making it a valuable option for scar management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of fractional carbon dioxide laser therapy for burn scars: a meta-analysis. Zhang, C., Yin, K., Shen, YM.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 170 burn patients undergoing fractional CO2 laser therapy for hypertrophic scars, only 2.4% of treatment sessions resulted in adverse events, indicating that this therapy is generally safe.

Despite some minor side effects like increased pain and erythema, 97.1% of patients reported improvements in their scar symptoms, highlighting the efficacy of fractional CO2 laser therapy in managing hypertrophic burn scars.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Hypertrophic Burn Scars With Laser Therapy: A Review of Adverse Events. Won, P., Cooper, M., Gillenwater, TJ., et al.[2023]

In a study involving 11 patients with burn scars, treatment with fractional CO2 laser resulted in significant clinical improvement, as measured by the Vancouver scar scale, indicating its efficacy in scar reduction.

Histological analysis revealed that the treatment promoted the formation of new collagen fibers in the upper dermis, leading to smoother skin and improved tension, although some patients experienced postinflammatory hyperpigmentation and itching as side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dermal Remodeling of Burn Scar by Fractional CO2 Laser. Lee, SJ., Suh, DH., Lee, JM., et al.[2017]

Fractional CO2 laser procedures are safe and effective for skin rejuvenation and scar management, allowing for customized treatments based on individual skin features.

Very short-pulse-duration devices can provide significant improvements in scar tissue by inducing controlled thermal damage, leading to immediate relaxation of tension and long-term skin remodeling through molecular activation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Developments for Fractional Co2 Resurfacing for Skin Rejuvenation and Scar Reduction. Clementoni, MT., Pedrelli, V., Zaccaria, G., et al.[2020]

Fractional carbon dioxide laser treatment significantly improved the quality of postburn scars in patients with skin phototypes III to VI, with average scores increasing from 4.4 to 7.33 for physicians and from 5.35 to 7.5 for patients after one year.

While 60% of patients experienced mild hypochromia two months post-treatment, this decreased to only 15% after one year, indicating that while hypopigmentation can occur, it often resolves over time, especially in patients with darker skin types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractional Carbon Dioxide Laser in Patients with Skin Phototypes III to VI and Facial Burn Sequelae: 1-Year Follow-Up. Salles, AG., Luitgards, BF., Moraes, LB., et al.[2021]

In a study involving 10 patients with acne scars, higher-energy, low-density CO2 fractional laser treatment resulted in more significant clinical improvements (over 76%) compared to lower-energy, high-density treatment (51% to 75% improvement).

The findings suggest that using higher fluence settings may be more effective for treating acne scars and enlarged pores, although further research is needed to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower-fluence, higher-density versus higher-fluence, lower-density treatment with a 10,600-nm carbon dioxide fractional laser system: a split-face, evaluator-blinded study. Jung, JY., Lee, JH., Ryu, DJ., et al.[2015]

Ablative fractional CO2 laser treatment is safe and effective for improving hypertrophic burn scars, with significant reductions in scar severity observed even when treatment is initiated within 1 month after injury.

The study involved 221 patients and found that both early (within 3 months) and late (more than 12 months) treatments resulted in decreased hardness and redness of scars, indicating that early intervention can be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypertrophic Scar Improvement by Early Intervention With Ablative Fractional Carbon Dioxide Laser Treatment. Tan, J., Zhou, J., Huang, L., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11877625/

A Retrospective Analysis of the Effectiveness of Fractional ... AFCL is an effective treatment for linear scars. Early intervention, specifically within the first 6 months, leads to superior outcomes for atrophic scars.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666328725000021

Treatment of postburn hypertrophic scaring in skin of color ... Fractional CO2 laser therapy shows promise in managing mature hypertrophic burn scars, with improvement in scar appearance, functionality, and symptom relief.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33288326/

Fractional CO2 laser treatment for burn scar improvement We conducted a systematic review and meta-analysis to determine the efficacy of fractional CO 2 lasers in treating burn scars, and found that laser therapy ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/jocd.16708

Fractional CO2 Laser to Treat Surgical Scars: A System ... Both in RCT and non-RCT settings, fractional CO2 laser therapy exhibited the same efficacious outcomes, with MD values of −0.63 (95% CI: −1.15 ...

5. stemcellres.biomedcentral.com stemcellres.biomedcentral.com/articles/10.1186/s13287-023-03480-8

Efficacy of fractional CO2 laser in combination with stromal ... In our study, the additional injection of SVF to fractional CO2 laser treatment was associated with an improvement in burn scar severity ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34493423/

The efficacy and safety of fractional CO 2 laser therapy in ... Fractional CO2 laser therapy significantly improved both the signs and symptoms of burn scars. Considering potential limitations, more large- ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4645146/

Efficacy and Safety of Fractional CO2 Laser Resurfacing in ... Data from our study suggests that fractional laser resurfacing with CO2 laser is a safe and effective treatment option in post-burn and post-traumatic scars.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0305417920305490

Effectiveness and safety of ablative fractional CO2 laser for ... This study demonstrates that AFL-CO 2 is an effective and safe treatment modality for burn scars improving thickness, symptoms and quality of life of burn ...