RecruitingNot Applicable

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

United States42 participantsStarted 2020-08-21

Plain-language 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.

Who can participate

Age range18 Years – 99 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Strickland modified Total Active Motion (TAM)

Timeframe: At 3 months

Trial details

NCT IDNCT04322370

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05-17

Contact for this trial

Stephan Alvarez

352-294-5687 stephan.alvarez@surgery.ufl.edu

View on ClinicalTrials.gov More Flexor Tendon trials