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

Patients With Major Burn Injury in Formosa FunCost Explosion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03922399
• Other study ID #: 20180606R
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: March 8, 2019

Study information

• Verified date: April 2019
• Source: Shin Kong Wu Ho-Su Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 8, 2019
• Est. primary completion date: January 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burns
• Patients With Major Burn Injury in Formosa FunCost Explosion

Intervention

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

Locations

Country	Name	City	State
Taiwan	Shin Kong Wu Ho Su Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Shin Kong Wu Ho-Su Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Burn assessment by researchers	Burn scars are assessed using Vancouver scar scale by four plastic surgeons and a non-professional person.	Week 0
Secondary	Scar evaluation by sonography (selective)	Burn scars in lower extremity are measured using 2-D problem sonography machine.	Week 0
Secondary	Autonomic nervous system analysis (selective)	Autonomic nervous system analysis is performed by heart-rate variability machine (HRV MACHINE).	Week 0