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Trial registered on ANZCTR
Registration number
ACTRN12625000088448
Ethics application status
Approved
Date submitted
7/01/2025
Date registered
28/01/2025
Date last updated
28/01/2025
Date data sharing statement initially provided
28/01/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Safety and Feasibility Study of the Ligo In situ Bioprinting System
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Scientific title
Clinical Trial assessing the safety and feasibility of the Ligo In situ Bioprinting System for the direct application of cells and biomaterials to participants skin defects.
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Secondary ID [1]
313633
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LIGO-SKIN-A001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Skin wound
336197
0
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Condition category
Condition code
Skin
332731
332731
0
0
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Other skin conditions
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Surgery
332732
332732
0
0
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Other surgery
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Single arm, open label, non-randomised study designed to assess the safety and performance of the Ligo In situ Bioprinting System for the delivery of printed constructs, made from a patient’s own skin cells. The printed construct is formed in the target site by the in-situ gelation of a two part biomaterial system, with the patient's own skin cells incorporated into part one of the biomaterial system prior to application. This process is typically completed in a few minutes depending on the size and orientation of the skin defect.
Up to 10 participants will be enrolled to assess the safety of the Ligo In situ Bioprinting System in donor-site wounds of participants undergoing skin transplantation for soft tissue defect surgery.
On Day 0 at Baseline Visit (the day of the procedure), a printed construct will be applied to the wound site by the study staff and dressed with primary and outer dressings. Between days 2 and 4, the outer dressing will be changed if needed, leaving the primary dressing intact. Any localized or adverse events will be recorded. Between days 6 and 8, the dressings will be removed and the wound site will be assessed by Investigator. The wound will be monitored and assessed on a twice weekly basis until complete wound healing has been achieved. On the last visit scar assessment will be performed.
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Intervention code [1]
330226
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Treatment: Surgery
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Intervention code [2]
330317
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Treatment: Devices
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
340260
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Safety
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Assessment method [1]
340260
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Incidence of adverse events including localised infection and allergic reactions and incidence of serious adverse events including systemic reactions/sepsis etc as assessed by clinical examination.
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Timepoint [1]
340260
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Intraoperative and twice per week up to 4 weeks post procedure
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Secondary outcome [1]
443520
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Wound closure
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Assessment method [1]
443520
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Number of days until wound healing is achieved as assessed by the Investigator
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Timepoint [1]
443520
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Twice per week up to 4 weeks post procedure
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Eligibility
Key inclusion criteria
1. Male and female participants 18 years to 70 years of age (inclusive)
2. Combined TBSA of all full thickness defects 10% or less, who have undergone autologous skin grafting and who have confirmed at least 1 donor wound site with an even distribution of depth and extent of maximum 1% TBSA as judged by the Investigator.
3. Willing and able to provide informed consent and to complete a follow-up evaluation.
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Electrical burn injuries
2. Allergy or hypersensitivity to trypsin or compound sodium lactate solution (Hartmann’s Solution)
3. Hypersensitivity to any of the active substances or excipients of the printed construct
4. Any drugs or treatment that leads to Immunosuppression
5. Patients with diabetes mellitus
6. Smoker - including tobacco, vaping, nicotine patches etc, or someone who has been an active smoker in the previous 2 years
7. Pregnant or breastfeeding women
8. Currently enrolled in another trial studying experimental treatment
9. Any condition, in the opinion of the investigator, that would interfere with completion of the study including study assessments and procedures
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety
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Statistical methods / analysis
The pragmatic sample size calculation (n=10) is based on the study being a feasibility study investigating safety and feasibility of the Ligo In situ Bioprinting System. Therefore, analysis of the study endpoints will be done using descriptive statistics. Descriptive statistical variables will include the mean (with two-sided 95% confidence intervals), standard deviation, median, minimum, and maximum for continuous variables and frequency and percentage.
The analysis of the primary endpoint will be conducted in the Full Analysis Set (all participants that receive the printed construct) as the main analysis population, while the analysis of the secondary endpoint will be conducted in the Performance Analysis Set (participants who have at least one performance assessment).
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
10/02/2025
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Actual
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Date of last participant enrolment
Anticipated
30/06/2025
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Actual
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Date of last data collection
Anticipated
28/07/2025
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Actual
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Sample size
Target
10
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
27452
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Concord Repatriation Hospital - Concord
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Recruitment postcode(s) [1]
43563
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2139 - Concord
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Funding & Sponsors
Funding source category [1]
318103
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Commercial sector/Industry
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Name [1]
318103
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Ligo Medical Pty Ltd
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Address [1]
318103
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Country [1]
318103
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Ligo Medical Pty Ltd
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Address
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Country
Australia
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Secondary sponsor category [1]
320462
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None
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Name [1]
320462
0
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Address [1]
320462
0
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Country [1]
320462
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316749
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Bellberry Human Research Ethics Committee A
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Ethics committee address [1]
316749
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123 Glen Osmond Road Eastwood SA 5063
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Ethics committee country [1]
316749
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Australia
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Date submitted for ethics approval [1]
316749
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27/09/2024
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Approval date [1]
316749
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30/10/2024
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Ethics approval number [1]
316749
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Summary
Brief summary
This study is being done to evaluate the safety and performance of the Ligo system, an investigational treatment to print skin by combining a patient's own skin cells with a biomaterial directly in the wound site. The study hypothesis is that the use of the Ligo Bioprinting System is safe for use in participants with burn injuries involving less than ten percent Total Body Surface Area that requires skin grafting.. The Ligo System is new and considered to be experimental.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
138886
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Dr Joanneke Maitz
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Address
138886
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Concord Repatriation General Hospital, Hospital Rd, Concord NSW 2139
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Country
138886
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Australia
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Phone
138886
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+61 02 9767 9898
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Fax
138886
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Email
138886
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[email protected]
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Contact person for public queries
Name
138887
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Dr Joanneke Maitz
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Address
138887
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Concord Repatriation General Hospital, Hospital Rd, Concord NSW 2139
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Country
138887
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Australia
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Phone
138887
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+61 02 9767 9898
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Fax
138887
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Email
138887
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[email protected]
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Contact person for scientific queries
Name
138888
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Dr Joanneke Maitz
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Address
138888
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Concord Repatriation General Hospital, Hospital Rd, Concord NSW 2139
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Country
138888
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Australia
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Phone
138888
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+61 02 9767 9898
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Fax
138888
0
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Email
138888
0
[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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