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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03240718
Recruitment Status : Completed
First Posted : August 7, 2017
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

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.

Condition or disease Intervention/treatment Phase
Burns Procedure: Laser treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Controlled, Within-patient, Single-blinded Pilot Study to Evaluate the Efficacy of the Ablative Fractional CO2 Laser in the Treatment of Hypertrophic Scars in Adult Burn Patients
Study Start Date : February 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns Scars

Arm Intervention/treatment
Experimental: Laser treated HSc scar
Co2 laser treatment
Procedure: Laser treatment
CORE fractional CO2 laser treatment

No Intervention: Control scar
Standard care



Primary Outcome Measures :
  1. Skin Characteristics changes [ Time Frame: baseline, 12 weeks and 24 weeks ]
    Erythema, elasticity and thickness measures


Secondary Outcome Measures :
  1. Satisfaction Questionnaire [ Time Frame: baseline, 24 weeks ]
    Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240718


Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
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Principal Investigator: Bernadette Nedelec, PhD CRCHUM

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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT03240718    
Other Study ID Numbers: CE14-122
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Cicatrix, Hypertrophic
Burns
Wounds and Injuries
Cicatrix
Fibrosis
Pathologic Processes