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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
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.
Secondary ID [1] 313633 0
LIGO-SKIN-A001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin wound 336197 0
Condition category
Condition code
Skin 332731 332731 0 0
Other skin conditions
Surgery 332732 332732 0 0
Other surgery

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 330226 0
Treatment: Surgery
Intervention code [2] 330317 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340260 0
Safety
Timepoint [1] 340260 0
Intraoperative and twice per week up to 4 weeks post procedure
Secondary outcome [1] 443520 0
Wound closure
Timepoint [1] 443520 0
Twice per week up to 4 weeks post procedure

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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
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).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/02/2025
Actual
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
28/07/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27452 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 43563 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 318103 0
Commercial sector/Industry
Name [1] 318103 0
Ligo Medical Pty Ltd
Country [1] 318103 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Ligo Medical Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 320462 0
None
Name [1] 320462 0
Address [1] 320462 0
Country [1] 320462 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316749 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 316749 0
123 Glen Osmond Road Eastwood SA 5063
Ethics committee country [1] 316749 0
Australia
Date submitted for ethics approval [1] 316749 0
27/09/2024
Approval date [1] 316749 0
30/10/2024
Ethics approval number [1] 316749 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138886 0
Dr Joanneke Maitz
Address 138886 0
Concord Repatriation General Hospital, Hospital Rd, Concord NSW 2139
Country 138886 0
Australia
Phone 138886 0
+61 02 9767 9898
Fax 138886 0
Email 138886 0
[email protected]
Contact person for public queries
Name 138887 0
Dr Joanneke Maitz
Address 138887 0
Concord Repatriation General Hospital, Hospital Rd, Concord NSW 2139
Country 138887 0
Australia
Phone 138887 0
+61 02 9767 9898
Fax 138887 0
Email 138887 0
[email protected]
Contact person for scientific queries
Name 138888 0
Dr Joanneke Maitz
Address 138888 0
Concord Repatriation General Hospital, Hospital Rd, Concord NSW 2139
Country 138888 0
Australia
Phone 138888 0
+61 02 9767 9898
Fax 138888 0
Email 138888 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.