None listed
Conditions
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.
Interventions
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
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.
Sponsors
Ligo Medical Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
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.
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
Outcome results
None listed