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

NCT ID: NCT03922399

Last Updated: 2019-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-03-08

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

Conditions

Patients With Major Burn Injury in Formosa FunCost Explosion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Laser and Surgery in patients with major burn scars

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)

Group Type: OTHER

Laser and Surgery

Intervention Type: PROCEDURE

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

Interventions

Laser and Surgery

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shin Kong Wu Ho-Su Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

CHACHUN, CHEN

Plastic Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shin Kong Wu Ho Su Memorial Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

20180606R

Identifier Type: -

Identifier Source: org_study_id