CO2 Laser Revision for Burn Related Donor Site Scars

Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04456127
• Other study ID #: 2018-063
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 21, 2020
• Est. completion date: July 1, 2026

Study information

• Verified date: April 2024
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burn Scar
• Burns
• Cicatrix
• Scar
• Skin Graft Scar

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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