Mechanistic Basis of Ablative Carbon Dioxide Laser in Treating Hypertrophic Scars

NCT04736251 | Unknown

• 1 other identifier: RRK6716
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Burn Scar; Scar

Outcome Measures

Primary Outcomes (1)

• Detect the number of senescent cells and the sub-population of fibroblasts 12 months after the last CO2 laser therapy

  Measuring the proportion of senescent cells and the proportion and sub-population of fibroblasts following treatment to determine positive effect of CO2 laser therapy through histological assessment. In particular, to assess: 1. Changes in the proportion of senescent cells (marker: p16) and types of fibroblasts (αSMA and CD90/Thy1) from baseline at 3 weeks after 1st laser treatment. 2. Changes in the proportion of senescent cells (marker: p16) and types of fibroblasts (αSMA and CD90/Thy1) from baseline at 3 months after 1st laser treatment. 3. Changes in the proportion of senescent cells (marker: p16) and types of fibroblasts (αSMA and CD90/Thy1) from baseline at 6 months after 1st laser treatment. 4. Changes in the protortion of senescent cells (marker: p16) and types of fibroblasts (αSMA and CD90/Thy1) from baseline at 18 months after 1st laser treatment.

  18 months

Secondary Outcomes (9)

• Vancouver Scar Scale

  18 months

• Patient and Observer Scar Assessment Scale (POSAS)

  18 months

• Brisbane Burn Scar Impact Profile (BBSIP)

  18 months

• Health status

  18 months

• Quantify scar colour

  18 months

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patient with hypertrophic scarring as a result of deep dermal or full thickness burns/trauma sustained more than 12 months prior to recruitment.

You may qualify if:

• Adult patients aged ≥ 16years
• Patient with hypertrophic scarring as a result of deep dermal or full thickness burns/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 limb or trunk

You may not qualify if:

• 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, including intra-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 Paraffin Liquid Paraffin %w/w 50 50.)
• Patients with Fitzpatrick skin type of 5-6 due to nature of the skin
• 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 or eczema
• 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 Diabetes Mellitus, Addison's, Grave's and Crohn's Disease, 2. Systemic; Rheumatoid Arthritis, Multiple Sclerosis, Lups and Scleroderma).
• Known history of keloid scarring

Sponsors & Collaborators

• Naiem Moiemen: lead
• The Scar Free Foundation Centre for Conflict Wound Research: collaborator
• University of Birmingham: collaborator
• Welsh Centre for Burns and Plastic Surgery, Morriston Hospital: collaborator

Study Sites (1)

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

RECRUITING

Related Publications (22)

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• Andrews N, Jones LL, Moiemen N, Calvert M, Kinghorn P, Litchfield I, Bishop J, Deeks JJ, Mathers J; PEGASUS Study Group. Below the surface: Parents' views on the factors that influence treatment adherence in paediatric burn scar management - A qualitative study. Burns. 2018 May;44(3):626-635. doi: 10.1016/j.burns.2017.09.003. Epub 2017 Oct 12.

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• Chen YY, Patel KM, Imran R, Hassouna T, Amirize E, Abdulsalam A, Bishop J, Slade A, Ventura M, Yarrow J, Lord JM, Wilson Y, Moiemen NS. SMOOTH protocol: A pilot randomised prospective intra-patient single-blinded observational study for examining the mechanistic basis of ablative fractional carbon dioxide laser therapy in treating hypertrophic scarring. PLoS One. 2023 Sep 8;18(9):e0285230. doi: 10.1371/journal.pone.0285230. eCollection 2023.

  PMID: 37682920 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tissue (skin biopsy) and blood samples (plasma and serum)

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Naiem Moiemen, GMC

  University Hospital Birmingham NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Minnie Ventura, MSc

CONTACT

01213718220; Maximina.Ventura@uhb.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Burns and Plastics Consultant

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: February 3, 2021
• Study Start: December 9, 2019
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: November 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)