MoralityNCT06170424
Retrospective Analysis of Spray Skin Treats for Severe Burns
An observational study of Morality and Skin Graft Complications, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
This study investigated the efficacy of novel approach spray skin for extensive severe burns treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Morality, Skin Graft Complications
- What is being tested?
- spray skin
- Type of treatment
- Surgery or procedure
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2012to 31 Dec 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: severe burns patients with > 50% TBSA
Who may be able to join
- patients with > 50% TBSA
Who cannot join
- died within 1 week after admission
- admitted to hospital more than 1 week after injury
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Burn Surgery, The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
About this study
Official title: A Real-world 10-year Single Center Experience With Spray Skin in the Treatment of Extensive Severe Burns
This study investigated the efficacy of novel approach spray skin for extensive severe burns treatment.
Read the detailed description
Burns are a global public health problem. This study investigated the efficacy of novel approach spray skin (autologous skin cell suspension combined with split-thickness skin grafting, STSG) for extensive severe burns treatment.
We performed a real-world retrospective analysis of extensive burns patients (> 50% TBSA) from our hospital last 10 years.
- Conditions
- Morality, Skin Graft Complications
- Being tested
- spray skin, Control group
- Keywords
- spray skin, severe burn, microskin grafting
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spray skinProcedure or surgery
The patients who used the autologous skin cell suspension combined with skin grafting.
Control groupProcedure or surgery
The patients who used skin grafting.
| Study group | Role | What they receive |
|---|---|---|
| experimental gourp | The patients who used the autologous skin cell suspension combined with skin grafting. Receives: Procedure: spray skin | |
| Control group | The patients who used split-thickness skin grafting. Receives: Procedure: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate
Patient survival during hospitalization
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
complication of skin graft
the survival of grafting skin
Measured: the take rate in the postoperative day 30, 60, 90
length of hospital
The time during which the patient was hospitalized
Measured: through study completion, usually no more than 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start1 Jan 2012
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MoralityStudies 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
- Retrospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Jiayuan, 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
- NCT06170424
- Sponsor's protocol ID
- SYSU-FAH-2019287
- Status last verified
- Dec 2023
- First submitted
- 3 Dec 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Subjects' private information needs to be protected, and contact the investigator if necessary.
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world 10-year Single Center Experience With Spray Skin in the Treatment of Extensive Severe Burns
- ClinicalTrials.gov ID
- NCT06170424
- Acronym / sponsor ID
- SYSU-FAH-2019287
- Conditions
- Morality, Skin Graft Complications
- Keywords
- spray skin, severe burn, microskin grafting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 14 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.
This study investigated the efficacy of novel approach spray skin for extensive severe burns treatment.
Detailed description
Burns are a global public health problem. This study investigated the efficacy of novel approach spray skin (autologous skin cell suspension combined with split-thickness skin grafting, STSG) for extensive severe burns treatment.
We performed a real-world retrospective analysis of extensive burns patients (> 50% TBSA) from our hospital last 10 years.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental gourp | – | Procedure: spray skinThe patients who used the autologous skin cell suspension combined with skin grafting. |
| Control group | – | Procedure: Control groupThe patients who used split-thickness skin grafting. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- severe burns patients with > 50% TBSA
Key inclusion criteria (1 listed)
- patients with > 50% TBSA
Key exclusion criteria (2 listed)
- died within 1 week after admission
- admitted to hospital more than 1 week after injury
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 skinThe patients who used the autologous skin cell suspension combined with skin grafting. | Procedure or surgery | experimental gourp |
| Control groupThe patients who used skin grafting. | Procedure or surgery | Control group |
Primary outcome
survival rate
Time frame: through study completion, an average of 1 year
Patient survival during hospitalization
2 secondary outcomes
complication of skin graft
Time frame: the take rate in the postoperative day 30, 60, 90
length of hospital
Time frame: through study completion, usually no more than 6 months
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 14 Dec 2023.
- Individual participant dataSharing planned: No. Subjects' private information needs to be protected, and contact the investigator if necessary.
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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 Morality and Skin Graft Complications, 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 1 inclusion and 2 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 14 Dec 2023. 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?
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?
survival rate (time frame: through study completion, an average of 1 year). 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 14 Dec 2023.