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Biological Skin Graft With Keratinocyte-stem Cell Co-cultre for Burn Patients

NCT05652816 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-12-15

No results posted yet for this study

Summary

The goal of this clinical trial is to test whether artificial skin graft can substitute autologous skin graft in current burn treatment. The main question it aims to answer is:

• Can artificial skin graft result in better wound healing compared to the current burn treatment; autologous skin graft?

You will:

* Undergo debridement surgery
* Receive artificial skin graft as an alternative to autologous skin graft
* Undergo biopsy procedure of burn area

If there is a comparison group: Researchers will compare autologous skin graft group to see the wound healing process

Conditions

  • Burn Degree Second
  • Burn Degree Third

Interventions

PROCEDURE

Split-thickness skin graft

Transplantation of autologous skin to burn area

BIOLOGICAL

Artificial skin graft

Decellularized amnion membrane formed into 3-D matrix

BIOLOGICAL

Artificial skin graft co-culture

Decellularized amnion membrane formed into 3-D matrix seeded with autologous keratinocyte co-cultured with amnion epithelial stem cells

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-06
Primary Completion
2023-12-31
Completion
2024-12-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05652816 on ClinicalTrials.gov