Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000522415
Ethics application status
Approved
Date submitted
4/04/2025
Date registered
26/05/2025
Date last updated
26/05/2025
Date data sharing statement initially provided
26/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A safety and efficacy study of the B3 gel in improving functional outcomes following digital flexor or extensor tenolysis in participants with previous tendon injury in the hand.
Scientific title
A First-in human study evaluating the safety and efficacy of TYBR Health B3 GEL in Flexor or Extensor Tendon Tenolysis
Secondary ID [1] 314126 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tendon Injury 336931 0
Condition category
Condition code
Injuries and Accidents 333399 333399 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a first in human, prospective, single-arm, interventional study evaluating the safety and efficacy of the B3 gel in the protection of repaired tendons from scars and improving recovery following digital flexor or extensor tenolysis (tendon repair surgery) in participants with previous tendon injury in the hand.

After the tendon is separated from any scar tissue in your hands during surgery, the B3 Gel will be applied along the entire length of the tendon. The surgeon will decide how much gel to use to make sure the tendon is fully covered. Once the gel is applied, the surgical wound will be closed.

The study procedure will take approximately 60 minutes and will be performed by a qualified hand surgeon in an operating room. Adherence to the intervention will be assessed through follow-up visits performed by the study team as well as a review of medical records.


Intervention code [1] 330708 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340978 0
Incidence of post-tenolysis complications (i.e., infection, tendon rupture, wound dehiscence, and adhesion formation), and all safety related adverse events to B3 Gel.
Timepoint [1] 340978 0
Daily post-procedure up to study exit (168 days post procedure)
Secondary outcome [1] 445666 0
Change in finger motion compared to historical data derived from the literature
Timepoint [1] 445666 0
At Visits 3 (day 15 post procedure) through End of Study (168 days post procedure)/Early Withdrawal Visit compared to Visit 1 (screening/pre- treatment).
Secondary outcome [2] 446710 0
Any change in functional outcomes compared to historical data derived from the literature
Timepoint [2] 446710 0
At Visits 3 (day 15 post procedure) through End of Study (168 days post procedure)/Early Withdrawal Visit
Secondary outcome [3] 446711 0
Any change in post-operative pain to the repaired finger
Timepoint [3] 446711 0
At visits 3 (day 15 post procedure) through End of Study (168 days post procedure)/Early Withdrawal Visit.

Eligibility
Key inclusion criteria
1. Patient willing and able to provide a signed Patient Informed Consent Form
2. Stated willingness to comply with all study procedures
3. Male or female, aged 18 years of age or older
4. Flexor (zone 1-3) or extensor tendon injury (zone 1-5) with at least 3 months post-index procedure
5. Patient willing and able to follow the study instructions including completion of all required study procedures and visits.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Currently taking corticosteroids, immune modifiers, or undergoing chemotherapy.
2. Pregnancy, breastfeeding, severe systemic comorbidities, or other medical conditions that would affect comparative measures
3. Any condition(s) which, in the opinion of the Investigator, may impact the participant’s ability to properly follow-up or otherwise be at-risk for following protocol instructions
4. Known allergies to porcine products
5. Currently participating or planning to participate in an investigational drug, biologic or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints

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/efficacy
Statistical methods / analysis
Descriptive statistics will be used to provide an overview of the safety and efficacy results. In accordance with the clinical feasibility study design, no formal sample size calculation has been performed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 27692 0
Gold Coast University Hospital - Southport
Recruitment hospital [2] 27693 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 27695 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 43881 0
4215 - Southport
Recruitment postcode(s) [2] 43882 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 43884 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 318634 0
Commercial sector/Industry
Name [1] 318634 0
TYBR Australia Pty Ltd
Country [1] 318634 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
TYBR Australia Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 321052 0
None
Name [1] 321052 0
Address [1] 321052 0
Country [1] 321052 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317239 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 317239 0
Ethics committee country [1] 317239 0
Australia
Date submitted for ethics approval [1] 317239 0
19/02/2025
Approval date [1] 317239 0
07/04/2025
Ethics approval number [1] 317239 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140442 0
Dr Randipsingh Bindra
Address 140442 0
Gold Coast University Hospital, 1 Hospital Blvd, Southport, QLD, 4215
Country 140442 0
Australia
Phone 140442 0
+61 421 595 857
Fax 140442 0
Email 140442 0
[email protected]
Contact person for public queries
Name 140443 0
Mr Nick McCoy
Address 140443 0
C/- Business Synectics Pty Ltd, Level 10, 30 Collins Street, VIC, 3000
Country 140443 0
Australia
Phone 140443 0
+1 214 457 1996
Fax 140443 0
Email 140443 0
[email protected]
Contact person for scientific queries
Name 140444 0
Dr Randipsingh Bindra
Address 140444 0
Gold Coast University Hospital, 1 Hospital Blvd, Southport, QLD, 4215
Country 140444 0
Australia
Phone 140444 0
+61 421 595 857
Fax 140444 0
Email 140444 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: IPD will not be available



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.