BurnsNCT04772573
The Treatment Challenges and Limitation in High-Voltage Pediatric Electrical Burn at Rural Area
An observational study of Burns and Electrical Burn, run by S.K. Lerik General Hospital at 1 site in Indonesia.
Trial summary
A case of high-voltage pediatric electrical burn involving a fully conscious 13-year old boy who was admitted to the emergency room after being electrocuted by high-voltage power cable, with superficial partial thickness burn over right arm, trunk, and left leg (26% of total body surface area) with cardiac abnormality… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Burns, Electrical Burn, Burn Degree Second
- How many people
- 1 participants
- Where
- 1 siteIndonesia
- Study dates
- 7 Aug 2017to 10 Aug 2018
- Phase
- Observational
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with acute electrical burn wound
Who may be able to join
- patient with acute electrical burn wound
Who cannot join
- patient does not want to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Treatment Challenges and Limitation in High-Voltage Pediatric Electrical Burn at Rural Area: A Case Report
A case of high-voltage pediatric electrical burn involving a fully conscious 13-year old boy who was admitted to the emergency room after being electrocuted by high-voltage power cable, with superficial partial thickness burn over right arm, trunk, and left leg (26% of total body surface area) with cardiac abnormality e.g. tachycardia and non-specific ST depression. Treatments were based on Australian New Zealand Burns Association algorithm with several modifications, i.e. administering lower concentration of oxygen with nasal cannula instead of non-rebreathing mask and intravenous Ketorolac and Metamizole as analgesic instead of morphine due to limitation in infrastructure and knowledge. The patient underwent surgical debridement and strict observation with no signs of abnormality found during hospital stay. Wound dressing consisted of silver sulfadiazine, Sofra-tulle® and dry sterile gauze were used until epithelialization. After the wound healed, the patient resumed wearing elastic bandage and moisturizer on the wound area. The patient was observed daily through 7 days of hospitalization and followed-up for 1 year, achieving normal physiologic function of the affected area but unsatisfactory esthetic result. This case report showed that there is still a lack of burn prevention programs in the rural area, resulted in inadequate first aid application for electrical burn. There is a need for acknowledging and maximizing the implementation of available standardized guidelines e.g. Australian New Zealand Burns Association by giving homogenized training to personnel as well as providing feasible equipment, and then followed by strict monitoring for the patient. The focus of the burn program should also include burn rehabilitation, psychosocial needs and any complaints needing expert opinion in an outpatient setting in addition to adequate burn management for life saving and good wound healing.
- Conditions
- Burns, Electrical Burn, Burn Degree Second, Burn Scar
- Medical subject headings
- Burns, Burns, Electric
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing
The healing rate of burn wound
Measured: 1 month
Secondary outcomes (1)
Burn Scar
The appearance and function of the scar and the affected areas
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start7 Aug 2017
- Primary completion10 Aug 2018
- Study completion10 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- S.K. Lerik General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Leonard Suryadinata, S.K. Lerik General Hospital
- Investigators
- Adi Basuki, MD, Principal investigator, S.K.Lerik Public Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772573
- Sponsor's protocol ID
- SKL002
- Status last verified
- Feb 2021
- First submitted
- 24 Feb 2021
- Last updated
- 1 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment Challenges and Limitation in High-Voltage Pediatric Electrical Burn at Rural Area: A Case Report
- ClinicalTrials.gov ID
- NCT04772573
- Acronym / sponsor ID
- SKL002
- Conditions
- Burns, Electrical Burn, Burn Degree Second, Burn Scar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- S.K. Lerik General HospitalUniversity, hospital or other
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 10 Aug 2018 (actual)
- Study completion
- 10 Aug 2018 (actual)
- First posted
- 26 Feb 2021 (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.
A case of high-voltage pediatric electrical burn involving a fully conscious 13-year old boy who was admitted to the emergency room after being electrocuted by high-voltage power cable, with superficial partial thickness burn over right arm, trunk, and left leg (26% of total body surface area) with cardiac abnormality e.g. tachycardia and non-specific ST depression. Treatments were based on Australian New Zealand Burns Association algorithm with several modifications, i.e. administering lower concentration of oxygen with nasal cannula instead of non-rebreathing mask and intravenous Ketorolac and Metamizole as analgesic instead of morphine due to limitation in infrastructure and knowledge. The patient underwent surgical debridement and strict observation with no signs of abnormality found during hospital stay. Wound dressing consisted of silver sulfadiazine, Sofra-tulle® and dry sterile gauze were used until epithelialization. After the wound healed, the patient resumed wearing elastic bandage and moisturizer on the wound area. The patient was observed daily through 7 days of hospitalization and followed-up for 1 year, achieving normal physiologic function of the affected area but unsatisfactory esthetic result. This case report showed that there is still a lack of burn prevention programs in the rural area, resulted in inadequate first aid application for electrical burn. There is a need for acknowledging and maximizing the implementation of available standardized guidelines e.g. Australian New Zealand Burns Association by giving homogenized training to personnel as well as providing feasible equipment, and then followed by strict monitoring for the patient. The focus of the burn program should also include burn rehabilitation, psychosocial needs and any complaints needing expert opinion in an outpatient setting in addition to adequate burn management for life saving and good wound healing.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with acute electrical burn wound
Key inclusion criteria (1 listed)
- patient with acute electrical burn wound
Key exclusion criteria (1 listed)
- patient does not want to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Wound healing
Time frame: 1 month
The healing rate of burn wound
1 secondary outcome
Burn Scar
Time frame: 1 year
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 1 Mar 2021.
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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.
Adi Basuki, MD principal investigator
S.K.Lerik Public Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burns and Electrical Burn, run by S.K. Lerik General Hospital at 1 site in Indonesia.
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 1 inclusion and 1 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 1 Mar 2021. 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 Indonesia. 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?
Wound healing (time frame: 1 month). 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 1 Mar 2021.