Spray Skin Treats for Pediatric Burns | NCT06182345

Studies
Spray Skin Treats for Pediatric Burns

NCT06182345

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Status

Unknown status

Last Update Posted

Feb 8, 2024Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Pediatric Burn

Interventions

spray skin
skin graft

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2012Actual

Primary Completion Date

Jun 30, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Dec 13, 2023

First Submission Date that Met QC Criteria

Dec 23, 2023

First Posted Date

Dec 26, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2024

Last Update Posted Date

Feb 8, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hu Zhicheng, Professor, First Affiliated Hospital, Sun Yat-Sen UniversityPrincipal Investigator

Lead Sponsor

First Affiliated Hospital, Sun Yat-Sen UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experiment gourp		Autologous skin cell suspension combined with autologous skin graft was used to treat burn wound	Procedure: spray skin
Control group		Autologous skin graft was used to treat burn wound	Procedure: skin graft

Interventions

Name	Type	Description	Arm Group Labels	Other Names
spray skin	Procedure	autologous skin cell suspension combined with skin graft	Experiment gourp

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
take rate	take rate of skin graft	postoperative day 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
complication rate	after skin grafting, skin infection, necrosis, subcutaneous hematoma, etc	through study completion, an average of 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

burn for any reasons
Children

Exclusion Criteria:

Combined with mental illness
Congenital immune disease
Severe cardiopulmonary failure，etc

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children with burns from various reasons

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhicheng Hu	Contact	02087338235		willway128@163.com
Shushan Huang	Contact	02087330631		zsyyiec2020@mail.sysu.edu.cn

Overall Officials

Name	Affiliation	Role
Jiayuan Zhu	First Affiliated Hospital, Sun Yat-Sen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Burn Surgery, The First Affiliated Hospital of Sun Yat-sen University	Recruiting	Guangzhou	Guangdong	510080	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016038	Skin Transplantation

Ancestor Terms

ID	Term
D016378	Tissue Transplantation
D064987	Cell- and Tissue-Based Therapy
D001691	Biological Therapy
D013812	Therapeutics

Browse Leaves

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Browse Branches

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