CO2 Laser Revision for Burn Related Donor Site Scars

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Burn Scar Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Scar Skin Graft Scar

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

≥ 18 years of age
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

Pregnancy or nursing
Oral retinoid medication use within the past 6 months
Medical history of Ehlers-Danlos syndrome, AIDS
Nutritional deficiencies in the opinion of the investigator that would affect wound healing
Wounds complicated by clinically significant infection within past 30 days

Treatment and study plan

Fractional CO2 laser

Procedure

The UltraPulse® fractional ablative CO2 Laser will be employed with the DeepFX™ hand piece. Number of passes and laser settings, including fluency, density, spot size, will be chosen during the time of treatment as determined by the operating surgeon.

Primary outcomes

Comparison of Patient and Observer Scar Assessment Scale, VSS, and Delfin Instruments

Time frame: 2 months

The primary endpoint will be assessment of control and treatment halves at follow-up evaluation completed 2 months ± 2 weeks after the final laser treatment.

The change in scale measure from baseline to date of assessment will be used to compare treatment vs control scar halves. This will be calculated and compared using paired t-test with a p-value of 0.05 as the cutoff for significance.

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Registry information

Official study title

Ablative Fractional CO2 Laser Revision for Burn Related Donor Site Scars: A Pilot Randomized Controlled Trial

Important dates

Study start: 2020
Primary completion: 2024
Study completion: 2026
First posted: Jul 2, 2020
Registry last updated: May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting