None listed
Conditions
Brief summary
This is a first in human, prospective, multicentre, single arm feasibility study of the B3 gel. Tendons connect muscles to bones, helping transmit forces needed for body movement. In the hand, flexor tendons help fingers bend, and extensor tendons help fingers to straighten. Scar tissue forming around tendons can cause pain/discomfort and difficulty with movement. The B3 Gel acts like a casing for hand tendons after tenolysis surgery (done to free up tendons in the hand). The gel will be applied between hand tendons and other tissues. After standard surgery to separate tendons from scar tissue, B3 Gel will be applied along the tendons. The gel will be applied using an applicator, which mixes proteins and a salt solution to create the gel and then applies it precisely. In this study, participants will have tenolysis surgery as per standard practice and will have the B3 Gel applied as part of this procedure. After the procedure, participants will be followed for up to 169 days.
Interventions
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 muc
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.
Sponsors
TYBR Australia 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 No maximum
Healthy volunteers
No
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.
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
Outcome results
None listed