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

NCT ID: NCT03240718

Last Updated: 2017-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Laser treated HSc scar

Co2 laser treatment

Group Type: EXPERIMENTAL

Laser treatment

Intervention Type: PROCEDURE

CORE fractional CO2 laser treatment

Control scar

Standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Laser treatment

CORE fractional CO2 laser treatment

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernadette Nedelec, PhD

Role: PRINCIPAL_INVESTIGATOR

CRCHUM

Other Identifiers

CE14-122

Identifier Type: -

Identifier Source: org_study_id