NCT05652816

Brief 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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Sep 2022

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

September 6, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 15, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 15, 2022

Status Verified

December 1, 2022

Enrollment Period

1.3 years

First QC Date

November 29, 2022

Last Update Submit

December 8, 2022

Conditions

Burn Degree SecondBurn Degree Third

Keywords

artificial skin graftkeratinocyteamnion epithelial stem cellsburn

Outcome Measures

Primary Outcomes (42)

  • Burn thickness

    Thickness of burn evaluation using Rule of 9

    Day of surgery

  • Burn thickness

    Thickness of burn evaluation using Rule of 9

    Day 7 after surgery

  • Burn thickness

    Thickness of burn evaluation using Rule of 9

    Day 14 after surgery

  • Burn thermography

    Thermography evaluation using FLIRONE

    Day of surgery

  • Burn thermography

    Thermography evaluation using FLIRONE

    Day 7 after surgery

  • Burn thermography

    Thermography evaluation using FLIRONE

    Day 14 after surgery

  • Systemic clinical evaluation

    Mean arterial pressure measurement

    Day of surgery

  • Systemic clinical evaluation

    Mean arterial pressure measurement

    Day 7 after surgery

  • Systemic clinical evaluation

    Mean arterial pressure measurement

    Day 14 after surgery

  • Systemic clinical evaluation

    lactate measurement

    Day of surgery

  • Systemic clinical evaluation

    lactate measurement

    Day 7 after surgery

  • Systemic clinical evaluation

    lactate measurement

    Day 14 after surgery

  • Systemic clinical evaluation

    procalcitonin measurement

    Day of surgery

  • Systemic clinical evaluation

    procalcitonin measurement

    Day 7 after surgery

  • Systemic clinical evaluation

    procalcitonin measurement

    Day 14 after surgery

  • Systemic clinical evaluation

    urine excretion rate measurement

    Day of surgery

  • Systemic clinical evaluation

    urine excretion rate measurement

    Day 7 after surgery

  • Systemic clinical evaluation

    urine excretion rate measurement

    Day 14 after surgery

  • Histoarchitecture evaluation

    Haematoxylin \& Eosin staining

    Day of surgery

  • Histoarchitecture evaluation

    Haematoxylin \& Eosin staining

    Day 14 after surgery

  • Histoarchitecture evaluation

    Movat's Pentachrome staining

    Day of surgery

  • Histoarchitecture evaluation

    Movat's Pentachrome staining

    Day 14 after surgery

  • Immunohistochemistry

    collagen-1 labelling

    Day of surgery

  • Immunohistochemistry

    collagen-1 labelling

    Day 14 after surgery

  • Immunohistochemistry

    collagen-3 labelling

    Day of surgery

  • Immunohistochemistry

    collagen-3 labelling

    Day 14 after surgery

  • Immunohistochemistry

    von Willebrand labelling

    Day of surgery

  • Immunohistochemistry

    von Willebrand labelling

    Day 14 after surgery

  • Immunohistochemistry

    alpha-Smooth Muscle Actin labelling

    Day of surgery

  • Immunohistochemistry

    alpha-Smooth Muscle Actin labelling

    Day 14 after surgery

  • Wound healing relative gene expression

    TGFB1

    Day of surgery

  • Wound healing relative gene expression

    TGFB1

    Day 14 after surgery

  • Wound healing relative gene expression

    TGFB3

    Day of surgery

  • Wound healing relative gene expression

    TGFB3

    Day 14 after surgery

  • Wound healing relative gene expression

    Wnt4

    Day of surgery

  • Wound healing relative gene expression

    Wnt4

    Day 14 after surgery

  • Wound healing relative gene expression

    CTNNB1

    Day of surgery

  • Wound healing relative gene expression

    CTNNB1

    Day 14 after surgery

  • Wound healing relative gene expression

    MMP2

    Day of surgery

  • Wound healing relative gene expression

    MMP2

    Day 14 after surgery

  • Wound healing relative gene expression

    MMP9

    Day of surgery

  • Wound healing relative gene expression

    MMP9

    Day 14 after surgery

Study Arms (3)

STSG (Split-Thickness Skin Graft)

SHAM COMPARATOR

Patients treated with the standard treatment; autologous skin graft

Procedure: Split-thickness skin graft

Amnion Bilayer Only

EXPERIMENTAL

Patients treated with artificial graft only

Biological: Artificial skin graft

Amnion Bilayer seeded with co-culture

EXPERIMENTAL

Patients treated with artificial graft seeded with autologous keratinocyte co-cultured with amnion epithelial stem cells

Biological: Artificial skin graft co-culture

Interventions

Split-thickness skin graftPROCEDURE

Transplantation of autologous skin to burn area

STSG (Split-Thickness Skin Graft)
Artificial skin graftBIOLOGICAL

Decellularized amnion membrane formed into 3-D matrix

Amnion Bilayer Only
Artificial skin graft co-cultureBIOLOGICAL

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

Amnion Bilayer seeded with co-culture

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18 - 55
  • Area of burn \<50%
  • Acute phase burn (\<120 hrs)
  • Have not undergo any surgery for burn treatment

You may not qualify if:

  • Immunocompromised
  • Have comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RSUPN Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

RECRUITING

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Burns Unit, Cipto Mangunkusumo National Hospital

Study Record Dates

First Submitted

November 29, 2022

First Posted

December 15, 2022

Study Start

September 6, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

December 15, 2022

Record last verified: 2022-12

Locations

ID(1)