None listed
Conditions
Brief summary
The present clinical investigation aims to investigate the safety and feasibility of a novel bioscaffold in patients requiring defect repair and restoration of anatomic contour in non-critical sized, non-load bearing portions of the craniofacial skeleton following routine craniofacial operations. This is a first-in-human pilot study for this bioscaffold. It is hypothesised that there are no serious adverse events associated with the actv-graft bioscaffold.
Interventions
The intervention is a medical device. Participants undergoing a craniotomy/burr hole or rhinoplasty procedure will receive surgery with the use of the actv-graft bioscaffold instead of routine surgery. The bioscaffold is used for defect repair and restoration of anatomic contour following craniofacial procedures.
The actv-graft bioscaffold is implanted in the skull/nose of participants during cranial/nasal reconstruction. A sheet of Actv-graft bioscaffold is trimmed to size during surgery. It
The intervention is a medical device. Participants undergoing a craniotomy/burr hole or rhinoplasty procedure will receive surgery with the use of the actv-graft bioscaffold instead of routine surgery. The bioscaffold is used for defect repair and restoration of anatomic contour following craniofacial procedures. The actv-graft bioscaffold is implanted in the skull/nose of participants during cranial/nasal reconstruction. A sheet of Actv-graft bioscaffold is trimmed to size during surgery. It is inserted into the treatment area to fill the defect zone. (No need for sutures or other fixation devices) The time taken to handle, modify and implant the actv-graft bioscaffold is estimated to be 5 - 10 minutes depending on the shape of the defect. The duration of surgery may vary depending on the patient.
Sponsors
Global Surgical Innovations 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 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with defects up to 25mm diameter in the craniofacial skeleton created as a result of a surgical procedure (burr hole/craniotomy or rhinoplasty). 2. Patient deemed by the investigator to be a good candidate for augmenting routine closure and contouring of the craniomaxillofacial skeleton with a bioscaffold. 3. Age between 18 and 75 years. 4. Voluntary informed consent given prior to the performance of any study-specific procedures. 5. Psychosocially, mentally, and physically able to fully comply with the protocol including adhering to follow up schedules and requirements and filling out forms.
Exclusion criteria
1. Unable to provide voluntary informed consent 2. Critical sized bony defects 3. Load bearing reconstruction of craniofacial skeleton 4. Acute traumatic injury 5. Patient is breast feeding 6. Active infection–systemic or local 7. Pregnant, or wishes to become pregnant during the duration of the study 8. Systemic infectious disease including AIDS, HIV, hepatitis 9. Rheumatoid arthritis or other autoimmune disease 10. Transphenoidal endoscopic surgery 11. Active malignancy. Malignancies that are in remission and do not require further treatment or skin cancers such as non-melanoma skin carcinoma are permitted. Brain tumours not involving the skull and very unlikely to need local radiotherapy or chemotherapy within 6 months are also permitted. 12. Has a history of recent drug or alcohol abuse within the last 12 months. 13. Patient is a Prisoner. 14. Subject is currently participating in another research project.
Outcome results
None listed