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Recruiting NCT04322370

Prospective Randomized Blinded Trial of VersaWrap Tendon Protector for Zone 2 Flexor Tendon Injuries

Trial Parameters

Condition Flexor Tendon
Sponsor University of Florida
Study Type INTERVENTIONAL
Phase N/A
Enrollment 42
Sex ALL
Min Age 18 Years
Max Age 99 Years
Start Date 2020-08-21
Completion 2027-05-17
Interventions
Standard of Care Surgical ProcedureVersaWrap Treatment

Brief 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.

Eligibility Criteria

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

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