Outcome Evaluation for Burn Scar Therapy-laser and Surgery in Patients in Formosa Fun Coast Explosion

Study Overview
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Brief Summary
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Protocol title： Outcome evaluation for burn scar therapy-laser and surgery in patients in Formosa Fun Coast Explosion Objectives： The goal of this study is to evaluate the effectiveness of both lasers and operations on patients with major burn scar(>20% TBSA).

Detailed Description
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Background： There is no gold standard treatment for burn scar treatment, especially for those with major burn scar. In the Formosa Fun-Coast Dust Explosion in 2015, lots of patients with major burn scar suffer from severe pathologic burn scar syndromes. The gold of the study is to evaluate the efficacy of both lasers and operations on major burn scars treatment in the past two years. Study Design： To take the assessment of scar into account, the investigators use both objectives and subjective methods to evaluate the scar condition. In addition to the scale of scar, the investigators also use both sonography and HRV system to evaluate the expressions of scar. All evaluated tools used are the same as those used in 20160201R and 20160202R. The investigators also used previous records to check the patient's scar condition before these treatments. Hypothesis： After treatment, scar conditions should get better than before. However, the investigators need more scientific statistics to evaluate the improve rate. Key words： Burn scar, burn scar syndromes. Scar laser treatment

Official Title
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Outcome Evaluation for Burn Scar Therapy-laser and Surgery in Patients in Formosa Fun Coast Explosion

Conditions
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Patients With Major Burn Injury in Formosa FunCost Explosion

Intervention / Treatment
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* Procedure: Laser and Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >20% major burn scar, for 3 years patients in Formosa FunCost Explosion offering medical records, including laser and treatments available for questionnaire evaluation and others' evaluation those are willing to receive both sonography on scars and HRV evaluation Exclusion Criteria: those aren't willing to offer medical records those aren't willing to fill questionnaire those aren't willing to receive sonography on scars

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: Patients with major burn scar, after lasers treatment for three years Evaluation tool: questionnaires, sonography, HRV
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Laser and Surgery in patients with major burn scars<br>Evaluating patients with major burn scar after laser and surgical treatments Multiple-directions evaluation, including senior plastic resident, young resident, professional burn surgeons, senior nurse with burn scar, one non-medical patients(usually patients' family and friends) | Procedure: Laser and Surgery<br>* Laser and Surgery in patients with major burn scars Evaluating after three years treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients objective questionnaire | Patients objective questionnaires is used to evaluate subjects' sensation and life quality, in which pain, itchiness and sleep are evaluated by Visual Analogue Scale (VAS), Burn Itchiness Scale and Sleep Assessment Scale, respectively. | Week 0 | 
| Burn assessment by researchers | Burn scars are assessed using Vancouver scar scale by four plastic surgeons and a non-professional person. | Week 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar evaluation by sonography (selective) | Burn scars in lower extremity are measured using 2-D problem sonography machine. | Week 0 | 
| Autonomic nervous system analysis (selective) | Autonomic nervous system analysis is performed by heart-rate variability machine (HRV MACHINE). | Week 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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burn scar, laser, ultrapulse