CO2 Laser Revision for Burn Related Donor Site Scars

NCT04456127 | Active Not Recruiting FDA Device

• 1 other identifier: 2018-063
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Burn Scar; Scar; Skin Graft Scar

Keywords

laser

Outcome Measures

Primary Outcomes (1)

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

  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.

  2 months

Study Arms (2)

Standard of Care

NO INTERVENTION

Scar section does not receive CO2 laser therapy.

Factional CO2

EXPERIMENTAL

Scar section receives fractional CO2 laser therapy.

Procedure: Fractional CO2 Laser

Interventions

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.

Factional CO2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

MedStar Washington Hospital Center

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

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intra-subject comparison

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: July 2, 2020
• Study Start: January 21, 2020
• Primary Completion: May 6, 2024
• Study Completion: April 12, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)