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

C

Centre hospitalier de l'Université de Montréal (CHUM)

Status

Completed

Conditions

Burns

Treatments

Procedure: Laser treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT03240718
CE14-122

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

12 participants in 2 patient groups

Laser treated HSc scar
Experimental group
Description:
Co2 laser treatment
Treatment:
Procedure: Laser treatment
Control scar
No Intervention group
Description:
Standard care

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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