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

Not Applicable

Completed

• Conditions: Patients With Major Burn Injury in Formosa FunCost Explosion
• Interventions: Procedure: Laser and Surgery

• Registration Number: NCT03922399
• Lead Sponsor: Shin Kong Wu Ho-Su Memorial Hospital

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

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2018-11-28
• Primary Completion: 2019-01-27
• Study Completion: 2019-03-08
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-18
• Last Update Submitted: 2019-04-18
• Study First Posted: 2019-04-22
• Last Update Posted: 2019-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laser and Surgery in patients with major burn scars	Laser and Surgery	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)

Primary Outcome Measures

Name	Time	Method
Burn assessment by researchers	Week 0	Burn scars are assessed using Vancouver scar scale by four plastic surgeons and a non-professional person.
Patients objective questionnaire	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shin Kong Wu Ho Su Memorial Hospital; 🇨🇳 Taipei, Taiwan