Pilot Study of the Ablative Fractional CO2 Laser in Hypertrophic Scars in Adult Burn Patients

Centre hospitalier de l'Université de Montréal (CHUM)12 enrolled

Overview

This is a randomized, controlled, within-patient, single-blinded, pilot study that will evaluate the impact of laser treatment on burn HSc relative to self-matched control scars. The studied primary outcomes of treatment are scar pliability, thickness, vascularity, pain, itch and patient satisfaction.

Prior to treatment initiation, two independent scars sites will be selected and an anatomically- on each individual. At the selected treatment site the scar will be treated with the CORE fractional CO2 laser Participants will receive 3 treatment sessions scheduled 4 weeks apart. The scar sites will be evaluated at baseline, immediately before the 3rd treatment and 12 weeks after their final treatment session.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Burns

Interventions

Laser treatmentPROCEDURE

CORE fractional CO2 laser treatment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Fitzpatrick skin type \<IV (37), * Have sustained a thermal burn injury, * Have at least 2 independent sites that show clinical evidence of HSc, * Are 2 months or more post-injury. Exclusion Criteria: * Subjects with skin phototypes IV or higher, * With history of keloidal scarring, * Who have coagulation disorder, * Are taking immunosuppressive medications, * If the mechanism of injury is an electrical, chemical, or cold injury, * Any underlying active skin disease, * Have taken oral Isotreinoin within the last 6 months, * Photosensitivity or have taken photosensitizing medications, * Pregnancy, * Previous treatment with dermabrasion, chemical peel, laser or intense pulsed light treatment

Outcomes

Primary Outcomes

Skin Characteristics changes

Erythema, elasticity and thickness measures

Time frame: baseline, 12 weeks and 24 weeks

Secondary Outcomes

Satisfaction Questionnaire

Questionnaire

Time frame: baseline, 24 weeks

Data from ClinicalTrials.gov

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