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Completed

NCT Number: NCT03922399

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

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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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shin Kong Wu Ho Su Memorial Hospital

Taipei, 11101, Taiwan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • those aren't willing to offer medical records
  • those aren't willing to fill questionnaire
  • those aren't willing to receive sonography on scars

Treatment and study plan

Laser and Surgery

Procedure

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

Primary outcomes

  1. Patients objective questionnaire

    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.

  2. Burn assessment by researchers

    Time frame: Week 0

    Burn scars are assessed using Vancouver scar scale by four plastic surgeons and a non-professional person.

Secondary outcomes

  1. Scar evaluation by sonography (selective)

    Time frame: Week 0

    Burn scars in lower extremity are measured using 2-D problem sonography machine.

  2. Autonomic nervous system analysis (selective)

    Time frame: Week 0

    Autonomic nervous system analysis is performed by heart-rate variability machine (HRV MACHINE).

Sponsors and collaborators

Lead sponsor

Shin Kong Wu Ho-Su Memorial Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 22, 2019
Registry last updated
Apr 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.