NCT06182345

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
12 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 26, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 8, 2024

Status Verified

February 1, 2024

Enrollment Period

12.5 years

First QC Date

December 13, 2023

Last Update Submit

February 6, 2024

Conditions

Pediatric Burn

Keywords

Pediatric burnSpray skinskin graft

Outcome Measures

Primary Outcomes (1)

  • take rate

    take rate of skin graft

    postoperative day 4 weeks

Secondary Outcomes (1)

  • complication rate

    through study completion, an average of 6 months

Study Arms (2)

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

spray skinPROCEDURE

autologous skin cell suspension combined with skin graft

Experiment gourp
skin graftPROCEDURE

skin graft

Control group

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children with burns from various reasons

You may qualify if:

  • burn for any reasons
  • Children

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Burn Surgery, The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Interventions

Skin Transplantation

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsDermatologic Surgical ProceduresPlastic Surgery ProceduresSurgical Procedures, OperativeTransplantation

Study Officials

  • Jiayuan Zhu

    First Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhicheng Hu

CONTACT

02087338235willway128@163.com

Shushan Huang

CONTACT

02087330631zsyyiec2020@mail.sysu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 13, 2023

First Posted

December 26, 2023

Study Start

January 1, 2012

Primary Completion

June 30, 2024

Study Completion

December 31, 2024

Last Updated

February 8, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)