A Prospective Intra-patient Single-blinded Randomised Trial to Examine the Mechanistic Basis of fractiOnal Ablative carbOn Dioxide Laser Therapy in Treating Adult Burns and/or Trauma Patients With Hypertrophic Scarring
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Detect the number of senescent cells and the sub-population of fibroblasts 12 months after the last CO2 laser therapy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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:
- •Localised; Type 1 Diabetes Mellitus, Addison's, Grave's and Crohn's Disease,
- •Systemic; Rheumatoid Arthritis, Multiple Sclerosis, Lups and Scleroderma).
- •Known history of keloid scarring
结局指标
主要结局
Detect the number of senescent cells and the sub-population of fibroblasts 12 months after the last CO2 laser therapy
时间窗: 18 months
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.
次要结局
- Vancouver Scar Scale(18 months)
- Quantify scar thickness(18 months)
- Quantify scar volume(18 months)
- Patient and Observer Scar Assessment Scale (POSAS)(18 months)
- Health status(18 months)
- Brisbane Burn Scar Impact Profile (BBSIP)(18 months)
- Quantify scar colour(18 months)
- Quantify scar elasticity(18 months)
- Novel markers associated with scar formation, wound healing and variables of scar behaviours in response to CO2 laser therapy(18 months)
研究者
Naiem Moiemen
Burns and Plastics Consultant
University Hospital Birmingham NHS Foundation Trust