NCT06170424

Brief Summary

This study investigated the efficacy of novel approach spray skin for extensive severe burns treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

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
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
Last Updated

December 14, 2023

Status Verified

December 1, 2023

Enrollment Period

10 years

First QC Date

December 3, 2023

Last Update Submit

December 12, 2023

Conditions

MoralitySkin Graft Complications

Keywords

spray skin, severe burn, microskin grafting

Outcome Measures

Primary Outcomes (1)

  • survival rate

    Patient survival during hospitalization

    through study completion, an average of 1 year

Secondary Outcomes (2)

  • complication of skin graft

    the take rate in the postoperative day 30, 60, 90

  • length of hospital

    through study completion, usually no more than 6 months

Study Arms (2)

experimental gourp

The patients who used the autologous skin cell suspension combined with skin grafting.

Procedure: spray skin

Control group

The patients who used split-thickness skin grafting.

Procedure: Control group

Interventions

spray skinPROCEDURE

The patients who used the autologous skin cell suspension combined with skin grafting.

experimental gourp
Control groupPROCEDURE

The patients who used skin grafting.

Control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

severe burns patients with \> 50% TBSA

You may qualify if:

  • patients with \> 50% TBSA

You may not qualify if:

  • died within 1 week after admission
  • admitted to hospital more than 1 week after injury

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

Location

MeSH Terms

Conditions

Burns

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Jiayuan Zhu

    First Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 3, 2023

First Posted

December 14, 2023

Study Start

January 1, 2012

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

December 14, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Subjects' private information needs to be protected, and contact the investigator if necessary.

Locations

CN(1)