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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06170424
Other study ID # SYSU-FAH-2019287
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2012
Est. completion date December 31, 2022

Study information

Verified date December 2023
Source First Affiliated Hospital, Sun Yat-Sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date December 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - patients with > 50% TBSA Exclusion Criteria: - died within 1 week after admission - admitted to hospital more than 1 week after injury

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
spray skin
The patients who used the autologous skin cell suspension combined with skin grafting.
Control group
The patients who used skin grafting.

Locations

Country Name City State
China Department of Burn Surgery, The First Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary survival rate Patient survival during hospitalization through study completion, an average of 1 year
Secondary complication of skin graft the survival of grafting skin the take rate in the postoperative day 30, 60, 90
Secondary length of hospital The time during which the patient was hospitalized through study completion, usually no more than 6 months
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