Shin Kong Wu Ho Su Memorial Hospital
Taipei, 11101, Taiwan
NCT Number: NCT03922399
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).
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Notify Me20 year and older
All sexes
Interventional
Not applicable
Taipei, 11101, Taiwan
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Laser and Surgery in patients with major burn scars Evaluating after three years treatment
Time frame: Week 0
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.
Time frame: Week 0
Burn scars are assessed using Vancouver scar scale by four plastic surgeons and a non-professional person.
Time frame: Week 0
Burn scars in lower extremity are measured using 2-D problem sonography machine.
Time frame: Week 0
Autonomic nervous system analysis is performed by heart-rate variability machine (HRV MACHINE).
Shin Kong Wu Ho-Su Memorial Hospital
Other
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