Prospective Randomized Blinded Trial of VersaWrap Tendon Protector for Zone 2 Flexor Tendon Injuries
University of Florida
Summary
To analyze outcomes between patients with Z2FT injuries following repair, randomized to two groups. The first group will be the negative control, with no tendon wrap. The second group will have a VersaWrap Tendon Protector applied over the site of the tendon repair. VersaWrap is current SOC at UF.
Description
VersaWrap Tendon Protector is intended to manage and protect tendon injuries where there is no significant loss of tendon tissue. It functions by separating the healing tendon from surrounding tissues to facilitate tendon gliding and tendon healing. VersaWrap can be placed on, over, or around flexor tendons and remains in place until healing is complete and then is bioresorbed. VersaWrap is FDA cleared for the use in procedures where there is no significant loss of tendon tissue and is currently one of the standard of care treatments used for this injury at UF Health. VersaWrap Tendon Protect…
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adult patients presenting to the plastic surgery service with a zone 2 flexor tendon injury requiring surgical repair Exclusion Criteria: * Patients with a sensitivity or allergy to polysaccharides alginate, hyaluronic acid, or citrate * Patients with psychiatric or medical problems that preclude them from having surgery * Female patients that are pregnant or breastfeeding * Prisoners * Patients who are unwilling or unable to follow-up
Interventions
- ProcedureStandard of Care Surgical Procedure
Zone 2 Flexor Tendon surgical repair will be performed by the principal investigator per standard of care. The same technique of tendon repair will be performed for all patients.
- DeviceVersaWrap Treatment
is intended to manage and protect tendon injuries where there is no significant loss of tendon tissue
Location
- University of FloridaGainesville, Florida