Status:
RECRUITING
Prospective Randomized Blinded Trial of VersaWrap Tendon Protector for Zone 2 Flexor Tendon Injuries
Lead Sponsor:
University of Florida
Conditions:
Flexor Tendon
Eligibility:
All Genders
18-99 years
Phase:
NA
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 Vers...
Detailed 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...
Eligibility Criteria
Inclusion
- Adult patients presenting to the plastic surgery service with a zone 2 flexor tendon injury requiring surgical repair
Exclusion
- 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
Key Trial Info
Start Date :
August 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 17 2027
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04322370
Start Date
August 21 2020
End Date
May 17 2027
Last Update
March 17 2025
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610