Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
NCT04322370

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

Led by University of Florida · Updated on 2025-03-17

42

Participants Needed

1

Research Sites

351 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients presenting to the plastic surgery service with a zone 2 flexor tendon injury requiring surgical repair
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Florida

Gainesville, Florida, United States, 32610

Actively Recruiting

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Research Team

S

Stephan Alvarez

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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