CO2 Laser Revision for Burn Related Donor Site Scars

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Burn Scar; Scar; Skin Graft Scar
• Intervention / Treatment: Procedure: Fractional CO2 Laser

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melissa M McLawhorn; Phone Number: 202-877-6181; Email: Melissa.M.Mclawhorn@medstar.net

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; Scar section does not receive CO2 laser therapy.
Experimental: Factional CO2; Scar section receives fractional CO2 laser therapy.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2020
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: laser
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Fibrosis; Burns; Cicatrix
• Other Study ID Numbers: 2018-063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes