Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624001218583p
Ethics application status
Submitted, not yet approved
Date submitted
24/08/2024
Date registered
4/10/2024
Date last updated
4/10/2024
Date data sharing statement initially provided
4/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety and Feasibility of the actv-graft® Craniofacial Bioscaffold
Scientific title
A Pilot Study to Determine the Safety and Feasibility of the actv-graft® Bioscaffold for use in Craniofacial Reconstruction patients
Secondary ID [1] 312670 0
ACTV-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Craniofacial defect 334650 0
Condition category
Condition code
Surgery 331228 331228 0 0
Surgical techniques
Respiratory 331499 331499 0 0
Other respiratory disorders / diseases
Neurological 331500 331500 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 329196 0
Treatment: Devices
Intervention code [2] 329393 0
Treatment: Surgery
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339000 0
Safety
Assessment method [1] 339000 0
Rate of adverse device effects over study period. Examples of adverse device effects include: - implant displacement assessed with physical examination - infection assessed with physical examination (e.g. redness, swelling) and microbiological investigations
Timepoint [1] 339000 0
operatively, immediately post-operatively and at 1, 2, 3, 6, 12, 26 weeks post-operatively
Secondary outcome [1] 438227 0
Ease of use
Assessment method [1] 438227 0
Assessed by surgeons. Specific questions: - Length of surgery - In your opinion, what was the change in length of surgery time compared to routine/alternate procedures? (no change in surgical time, increased surgical time by___ minutes, reduced surgical time by ___ minutes) - Was the actv-graft bioscaffold easy to intra-operatively modify? Y/N comments - Was the actv-graft bioscaffold easy to implant? Y/N comments
Timepoint [1] 438227 0
immediately post-operatively
Secondary outcome [2] 438228 0
Restoration of anatomic contour
Assessment method [2] 438228 0
PHYSICAL EXAMINATION - Does the actv-graft treatment site feel smooth and even? Y/N describe..
Timepoint [2] 438228 0
1, 2, 3, 6, 12 weeks post-operatively
Secondary outcome [3] 438229 0
Satisfaction with surgery outcomes
Assessment method [3] 438229 0
Self-report. Participants will be asked specific questions. Questions for craniotomy participants: Are you satisfied with the overall outcome of the surgery? Y/N comments Are you happy with how your head feels after your procedure? Y/N comments Are you happy with how your head looks after your procedure? Y/N comments Questions for rhinoplasty participants: Are you satisfied with the overall outcome of the surgery? Y/N comments Are you happy with how your nose feels after your procedure? Y/N comments Are you happy with how your nose looks after your procedure? Y/N comments
Timepoint [3] 438229 0
26 weeks post-operatively

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

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
30/04/2025
Actual
Date of last data collection
Anticipated
30/10/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317106 0
Commercial sector/Industry
Name [1] 317106 0
Global Surgical Innovations Pty Ltd
Country [1] 317106 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Global Surgical Innovations Pty Ltd
Country
Australia
Secondary sponsor category [1] 319363 0
None
Name [1] 319363 0
Country [1] 319363 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315855 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 315855 0
Ethics committee country [1] 315855 0
Australia
Date submitted for ethics approval [1] 315855 0
17/07/2024
Approval date [1] 315855 0
Ethics approval number [1] 315855 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 136002 0
A/Prof James van Gelder
Address 136002 0
NSW Health, Concord Repatriation General Hospital, Hospital Rd, Concord NSW 2139
Country 136002 0
Australia
Phone 136002 0
+61297676416
Email 136002 0
James.VanGelder@health.nsw.gov.au
Contact person for public queries
Name 136003 0
Paraskevi Drakoulidou
Address 136003 0
Sydney Spine Institute, Suite 107, 3 Railway Pde 2134 BURWOOD NSW
Country 136003 0
Australia
Phone 136003 0
+610297155007
Email 136003 0
manager@sydneyspineinstitute.com.au
Contact person for scientific queries
Name 136004 0
Dr Philip Boughton
Address 136004 0
Global Surgical Innovations, Suite 107, 3 Railway Pde 2134 BURWOOD NSW
Country 136004 0
Australia
Phone 136004 0
+61 02 97155007
Email 136004 0
philip.boughton@globalsurgicalinnovations.com.au

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.