Pediatric BurnNCT06182345
Spray Skin Treats for Pediatric Burns
An observational study of Pediatric Burn, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The treatment of burns in children remains a global challenge. At present, the clinical treatment plan is still waiting for further improvement. This study intends to retrospectively analyze the experience of treating children burn in recent years and promote sharing and application. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pediatric Burn
- What is being tested?
- spray skin and skin graft
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2012to 31 Dec 2024
- How long will I take part?
- 1 Year
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with burns from various reasons
Who may be able to join
- burn for any reasons
- Children
Who cannot join
- Combined with mental illness
- Congenital immune disease
- Severe cardiopulmonary failure，etc
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Burn Surgery, The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Zhicheng Hu, doctor, +86 02087755766 ext. 8235, willway128@163.com
About this study
Official title: Spray Skin Treats in the Treatment of Pediatric Burns
The treatment of burns in children remains a global challenge. At present, the clinical treatment plan is still waiting for further improvement. This study intends to retrospectively analyze the experience of treating children burn in recent years and promote sharing and application.
Read the detailed description
The treatment of burns in children remains a global challenge. Children's burn wounds have many characteristics that are different from those of adults, such as easy deepening of the wound, uncooperation in dressing change, poor resistance and so on. At present, there are new dressing applications a nd surgery in clinical treatment, etc., but how to treat children to achieve better therapeutic effects still needs to be explored. This study intends to retrospectively analyze the experience of treating children burn in recent years and promote sharing and application.
- Conditions
- Pediatric Burn
- Being tested
- spray skin, skin graft
- Keywords
- Pediatric burn, Spray skin, skin graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spray skinProcedure or surgery
autologous skin cell suspension combined with skin graft
skin graftProcedure or surgery
skin graft
| Study group | Role | What they receive |
|---|---|---|
| Experiment gourp | Autologous skin cell suspension combined with autologous skin graft was used to treat burn wound Receives: Procedure: spray skin | |
| Control group | Autologous skin graft was used to treat burn wound Receives: Procedure: skin graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
take rate
take rate of skin graft
Measured: postoperative day 4 weeks
Secondary outcomes (1)
complication rate
after skin grafting, skin infection, necrosis, subcutaneous hematoma, etc
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start1 Jan 2012
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric BurnStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu Zhicheng, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Jiayuan Zhu, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182345
- Sponsor's protocol ID
- SYSU-FAH-20231208
- Status last verified
- Feb 2024
- First submitted
- 13 Dec 2023
- Last updated
- 8 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spray Skin Treats in the Treatment of Pediatric Burns
- ClinicalTrials.gov ID
- NCT06182345
- Acronym / sponsor ID
- SYSU-FAH-20231208
- Conditions
- Pediatric Burn
- Keywords
- Pediatric burn, Spray skin, skin graft
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Dec 2023 (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.
The treatment of burns in children remains a global challenge. At present, the clinical treatment plan is still waiting for further improvement. This study intends to retrospectively analyze the experience of treating children burn in recent years and promote sharing and application.
Detailed description
The treatment of burns in children remains a global challenge. Children's burn wounds have many characteristics that are different from those of adults, such as easy deepening of the wound, uncooperation in dressing change, poor resistance and so on. At present, there are new dressing applications a nd surgery in clinical treatment, etc., but how to treat children to achieve better therapeutic effects still needs to be explored. This study intends to retrospectively analyze the experience of treating children burn in recent years and promote sharing and application.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experiment gourp | – | Procedure: spray skinAutologous skin cell suspension combined with autologous skin graft was used to treat burn wound |
| Control group | – | Procedure: skin graftAutologous skin graft was used to treat burn wound |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with burns from various reasons
Key inclusion criteria (2 listed)
- burn for any reasons
- Children
Key exclusion criteria (3 listed)
- Combined with mental illness
- Congenital immune disease
- Severe cardiopulmonary failure，etc
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 |
|---|---|---|
| spray skinautologous skin cell suspension combined with skin graft | Procedure or surgery | Experiment gourp |
| skin graftskin graft | Procedure or surgery | Control group |
Primary outcome
take rate
Time frame: postoperative day 4 weeks
take rate of skin graft
1 secondary outcome
complication rate
Time frame: through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Jiayuan Zhu principal investigator
First Affiliated Hospital, Sun Yat-Sen University
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 Pediatric Burn, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 2 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: status not confirmed, as of the sponsor's last update on 8 Feb 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhicheng Hu (02087338235, willway128@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
take rate (time frame: postoperative day 4 weeks). 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 8 Feb 2024.