CO2 Laser Revision for Burn Related Donor Site Scars

NCT ID: NCT04456127

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-21
• Study Completion Date: 2026-04-12

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Standard of Care

Scar section does not receive CO2 laser therapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Factional CO2

Scar section receives fractional CO2 laser therapy.

Group Type: EXPERIMENTAL

Fractional CO2 Laser

Intervention Type: 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.

Interventions

Fractional CO2 Laser

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medstar Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

MedStar Washington Hospital Center

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

Countries

United States

Other Identifiers

2018-063

Identifier Type: -

Identifier Source: org_study_id