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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03922399
Enrollment
8
Registered
2019-04-22
Start date
2018-10-01
Completion date
2019-03-08
Last updated
2019-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients With Major Burn Injury in Formosa FunCost Explosion

Keywords

burn scar, laser, ultrapulse

Brief summary

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

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

Interventions

PROCEDURELaser and Surgery

Laser and Surgery in patients with major burn scars Evaluating after three years treatment

Sponsors

Shin Kong Wu Ho-Su Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Masking description

evaluating in different medical groups

Intervention model description

Patients with major burn scar, after lasers treatment for three years Evaluation tool: questionnaires, sonography, HRV

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. \>20% major burn scar, for 3 years 2. patients in Formosa FunCost Explosion 3. offering medical records, including laser and treatments 4. available for questionnaire evaluation and others' evaluation 5. those are willing to receive both sonography on scars and HRV evaluation

Exclusion criteria

1. those aren't willing to offer medical records 2. those aren't willing to fill questionnaire 3. those aren't willing to receive sonography on scars

Design outcomes

Primary

MeasureTime frameDescription
Patients objective questionnaireWeek 0Patients 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.
Burn assessment by researchersWeek 0Burn scars are assessed using Vancouver scar scale by four plastic surgeons and a non-professional person.

Secondary

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

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026