Retrospective Analysis of Spray Skin Treats for Severe Burns | NCT06170424

Studies
Retrospective Analysis of Spray Skin Treats for Severe Burns

NCT06170424

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Status

Completed

Last Update Posted

Dec 14, 2023Actual

Enrollment

85Actual

Phase

Not provided

Conditions

Morality
Skin Graft Complications

Interventions

spray skin
Control group

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

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2012Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Dec 3, 2023

First Submission Date that Met QC Criteria

Dec 12, 2023

First Posted Date

Dec 14, 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

Dec 12, 2023

Last Update Posted Date

Dec 14, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zhu Jiayuan, 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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

85Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
spray skin	Procedure	The patients who used the autologous skin cell suspension combined with skin grafting.	experimental gourp

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
survival rate	Patient survival during hospitalization	through study completion, an average of 1 year

Secondary Outcomes

Measure	Description	Time Frame
complication of skin graft	the survival of grafting skin	the take rate in the postoperative day 30, 60, 90
length of hospital	The time during which the patient was hospitalized

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with > 50% TBSA

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

severe burns patients with > 50% TBSA

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

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		Guangzhou	Guangdong	510080	China

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D002056	Burns

ID	Term
D014947	Wounds and Injuries

Intervention Browse Module

MeSH Terms

ID	Term
D035061	Control Groups

Ancestor Terms

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design

Browse Leaves

Not provided

Browse Branches

Not provided