Mechanistic Basis of Ablative Carbon Dioxide Laser in Treating Hypertrophic Scars

Last updated: November 5, 2021
Sponsor: Naiem Moiemen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Scar Tissue

Treatment

N/A

Clinical Study ID

NCT04736251
RRK6716
  • Ages > 16
  • All Genders

Study Summary

This is an observational cohort study which will look at the biomarkers from blood and tissue sample for adult patients with hypertrophic scarring due to burns/trauma incident over 12 months from date of recruitment. The study will assess the kinetics of the response to fractionated carbon dioxide laser therapy in hypertrophic scars.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients aged ≥ 16years
  • Patient with hypertrophic scarring as a result of deep dermal or full thicknessburns/trauma.
  • Trauma or Burn sustained more than 12 months prior to recruitment.
  • Treatment area to be ≥25cm2 confluent scarring with a comparable control scar on limbor trunk

Exclusion

General Exclusion Criteria:

  • Patients under 16 years of age
  • Previous laser therapy treatment to the study site
  • The use of recent (within 6 months) or concurrent invasive scar treatments, includingintra-lesional pharmaceuticals, micro needling or other laser modalities (e.g.Pulse-dye.)
  • Known allergy or contraindication to EMLA™ 5% Cream (Lidocaine 2.5% and Prilocaine 2.5%), Dermol 500TM (Benzalkonium Chloride 0.1%; Chlorhexidine Dihydrochloride 0.1%;Liquid Paraffin 2.5%; Isopropyl Myristate 2.5%) or 50:50 ointment (White Soft ParaffinLiquid Paraffin %w/w 50 50.)
  • Patients with Fitzpatrick skin type of 5-6 due to nature of the skin Laser Treatment Exclusion Criteria
  • The presence of acute infection at the proposed treatment site
  • Pregnancy or lactation
  • Patients with poorly controlled Diabetes mellitus HbA1C >9% or 75mmol/mol within last 3 months)
  • Patients experiencing acute exacerbation of Chronic skin diseases e.g. psoriasis oreczema
  • Immunosuppression (HIV, drugs with immunosuppressive effect)
  • Use of Roaccutane at any time within the last 6 months
  • Autoimmune disorders in active stage (for example: 1. Localised; Type 1 DiabetesMellitus, Addison's, Grave's and Crohn's Disease, 2. Systemic; Rheumatoid Arthritis,Multiple Sclerosis, Lups and Scleroderma).
  • Known history of keloid scarring

Study Design

Total Participants: 60
Study Start date:
December 09, 2019
Estimated Completion Date:
August 31, 2023

Study Description

Research has identified a gap in the knowledge of how fractional ablative carbon dioxide laser works on hypertrophic (thickened) scars. At present there is no accurate measure of how effective the benefit is objectively (medically), subjectively (to the patient) and histologically (on a microscopic level). Recent systematic review has shown an improvement in scars following laser therapy, however it found the quality of the data to be poor, confounded by multiple bias, identifying the lack of evidence to prove the worth and effectiveness of lasers. It concluded the need for more robust studies.

The study plans to observe a group of patients with hypertrophic burn and/or trauma scars (over 1 year old) and see what happens to their scars using the fractionated carbon dioxide laser therapy. Two similar scars will be identified per patient volunteer and will randomly allocate to receive either fractionated carbon dioxide laser therapy or standard care. An independent assessor will be blinded to the intervention and control scar sites.

The trial will aim to identify any biological markers found in participants blood and scar tissue and if they change through the course of and following laser therapy. This will help with understanding the mechanism of how the carbon dioxide laser works on scars.

As part of the evaluation of the impact of laser treatment on patients' quality of life, a patient reported outcome measures (PROMS) validation study will be carried out. PROMs describe how the patient is functioning or feeling without input from clinical staff providing a unique perspective of patients' lived experience of the disease as not all symptoms or impacts are obvious to clinicians. In order for PROMs to be effective in clinical trials and practice, they have to capture information on domains that matter to the patient. These include: scarring, movement and function, scar sensation, psychological distress, body image and confidence, engagement in activities, treatment burden and impact on relationships.

The scars will be assessed in a number of different ways; scar assessment tools/questionnaires, clinical inspection, photography, use of ultrasound, probes with suction to test the elasticity and pliability of the scars and the colour, microscopic evaluation and the identification of biomarkers from blood samples and scar and normal tissue biopsy.

Connect with a study center

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham,
    United Kingdom

    Active - Recruiting

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