CO2 Laser Treatment for Burn Scars

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

25 Participants Needed

Trial Summary

What is the purpose of this trial?

Scarring from burn wounds remains a chronic and often severe sequela of burn injury. Burn wounds may be left to heal by secondary intention or treated with surgical skin grafting; in both circumstances, significant scars likely result. When surgical skin grafting is employed, skin graft harvest sites ("donor sites") likewise result in clinically significant scars. This study will have interventional and observational components. Patients will receive the standard fractional ablative CO2 treatments to their scars resulting from burn wounds allowed to heal by secondary intention and/or those treated with skin grafts. These will be prospectively observed for the duration of the study as well as adjacent normal skin. In addition, a donor site that meets inclusion criteria that would not have otherwise received LSR will be identified as a treatment site. Patients with have one half of their donor sites randomized to standard of care (SOC) treatment, which consists of wound dressings, compression therapy, physical and occupational therapies and the other half randomized to SOC + ablative fractional CO2 laser therapy (LSR).

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 data supports the effectiveness of the treatment Fractional CO2 Laser for burn scars?

Research shows that Fractional CO2 Laser treatment significantly improves the appearance and symptoms of burn scars, including reducing scar thickness and improving scar elasticity. Studies also report that the treatment is generally safe with mild and tolerable side effects. ^{1 2 3 4 5}

Is CO2 laser treatment safe for burn scars?

CO2 laser treatment for burn scars is generally safe, with minimal adverse events reported. In a study of 544 treatments, only 2.4% experienced issues like increased pain or redness, and most patients saw improvements in their scars. ^{3 6 7 8 9}

How does the CO2 laser treatment for burn scars differ from other treatments?

The CO2 laser treatment for burn scars is unique because it uses a fractional laser that creates controlled thermal damage, which helps remodel the skin with fewer sessions compared to nonablative lasers. This treatment can be customized for each patient's skin, providing immediate relaxation of scar tension and promoting long-term improvements through molecular changes. ^{2 3 10 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

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]

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]

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]

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]

References

1. United States 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy of fractional carbon dioxide laser therapy for burn scars: a meta-analysis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Dermal Remodeling of Burn Scar by Fractional CO2 Laser. [2017]

4. Netherlands pubmed.ncbi.nlm.nih.gov

The efficacy and safety of fractional CO2 laser therapy in the treatment of burn scars: A meta-analysis. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Carbon dioxide laser treatment in burn-related scarring: A prospective randomised controlled trial. [2022]

6. United States 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. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Treatment of Hypertrophic Burn Scars With Laser Therapy: A Review of Adverse Events. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of ablative fractional CO2 laser for the treatment of burn scars: A case-control study. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Hypertrophic Scar Improvement by Early Intervention With Ablative Fractional Carbon Dioxide Laser Treatment. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

New Developments for Fractional Co2 Resurfacing for Skin Rejuvenation and Scar Reduction. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Early postoperative treatment of thyroidectomy scars using a fractional carbon dioxide laser. [2022]

12. United States 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. [2015]