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

Description

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

Flexor Tendon

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Flexor Tendon
Intervention / Treatment

-

Contacts and Locations

Gainesville

University of Florida, Gainesville, Florida, United States, 32610

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Adult patients presenting to the plastic surgery service with a zone 2 flexor tendon injury requiring surgical repair
  • * 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

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Florida,

Harvey Chim, MD, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

2027-05-17