Status:
UNKNOWN
Mechanistic Basis of Ablative Carbon Dioxide Laser in Treating Hypertrophic Scars
Lead Sponsor:
Naiem Moiemen
Collaborating Sponsors:
The Scar Free Foundation Centre for Conflict Wound Research
University of Birmingham
Conditions:
Burn Scar
Scar
Eligibility:
All Genders
16+ years
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...
Detailed 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 ben...
Eligibility Criteria
Inclusion
- 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
- General
Exclusion
- 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
- 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 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
Key Trial Info
Start Date :
December 9 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04736251
Start Date
December 9 2019
End Date
August 31 2023
Last Update
November 8 2021
Active Locations (1)
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1
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom