Patients With Major Burn Injury in Formosa FunCost ExplosionNCT03922399
Outcome Evaluation for Burn Scar Therapy-laser and Surgery in Patients in Formosa Fun Coast Explosion
A study testing Laser and Surgery in people with Patients With Major Burn Injury in Formosa FunCost Explosion, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Patients With Major Burn Injury in Formosa FunCost Explosion
- What is being tested?
- Laser and Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2018to 8 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- those aren't willing to offer medical records
- those aren't willing to fill questionnaire
- those aren't willing to receive sonography on scars
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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
- Being tested
- Laser and Surgery
- Keywords
- burn scar, laser, ultrapulse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser and SurgeryProcedure or surgery
Laser and Surgery in patients with major burn scars Evaluating after three years treatment
| Study group | Role | What they receive |
|---|---|---|
| Laser and Surgery in patients with major burn scars | Other | 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) Receives: Procedure: Laser and Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0
Burn assessment by researchers
Burn scars are assessed using Vancouver scar scale by four plastic surgeons and a non-professional person.
Measured: Week 0
Secondary outcomes (2)
Scar evaluation by sonography (selective)
Burn scars in lower extremity are measured using 2-D problem sonography machine.
Measured: Week 0
Autonomic nervous system analysis (selective)
Autonomic nervous system analysis is performed by heart-rate variability machine (HRV MACHINE).
Measured: Week 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start1 Oct 2018
- Primary completion27 Jan 2019
- Study completion8 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Major Burn Injury in Formosa FunCost ExplosionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with major burn scar, after lasers treatment for three years Evaluation tool: questionnaires, sonography, HRV
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHACHUN, CHEN, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922399
- Sponsor's protocol ID
- 20180606R
- Status last verified
- Apr 2019
- First submitted
- 28 Nov 2018
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: lasers treatments, especially patients with major burn cases, are widely used. Therefore, we still consider the results after three years' treatments.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Evaluation for Burn Scar Therapy-laser and Surgery in Patients in Formosa Fun Coast Explosion
- ClinicalTrials.gov ID
- NCT03922399
- Acronym / sponsor ID
- 20180606R
- Keywords
- burn scar, laser, ultrapulse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 27 Jan 2019 (actual)
- Study completion
- 8 Mar 2019 (actual)
- First posted
- 22 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with major burn scar, after lasers treatment for three years Evaluation tool: questionnaires, sonography, HRV
| Arm | Type | Receives |
|---|---|---|
| Laser and Surgery in patients with major burn scars | Other | Procedure: Laser and SurgeryEvaluating 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) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >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
Key exclusion criteria (3 listed)
- those aren't willing to offer medical records
- those aren't willing to fill questionnaire
- those aren't willing to receive sonography on scars
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser and SurgeryLaser and Surgery in patients with major burn scars Evaluating after three years treatment | Procedure or surgery | Laser and Surgery in patients with major burn scars |
Primary outcome
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.
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.
2 secondary outcomes
Scar evaluation by sonography (selective)
Time frame: Week 0
Autonomic nervous system analysis (selective)
Time frame: Week 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
- Individual participant dataSharing planned: Undecided. lasers treatments, especially patients with major burn cases, are widely used. Therefore, we still consider the results after three years' treatments.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser and Surgery in people with Patients With Major Burn Injury in Formosa FunCost Explosion, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients objective questionnaire (time frame: Week 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2019.