CO2 Laser Revision for Burn Related Donor Site Scars

MedStar Health

Status: Active, not recruiting

Conditions: Skin Graft Scar; Scar; Burn Scar

Treatments: Procedure: Fractional CO2 Laser

Study type: Interventional

Funder types: Other

Identifiers

NCT04456127

2018-063

Details and patient eligibility

About

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).

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

25 participants in 2 patient groups

Standard of Care

No Intervention group

Description:

Scar section does not receive CO2 laser therapy.

Factional CO2

Experimental group

Description:

Scar section receives fractional CO2 laser therapy.

Treatment:

Procedure: Fractional CO2 Laser