RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2020-08-21
Study Completion:2027-05-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04322370

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.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patients presenting to the plastic surgery service with a zone 2 flexor tendon injury requiring surgical repair
  1. * Patients with a sensitivity or allergy to polysaccharides alginate, hyaluronic acid, or citrate
  2. * Patients with psychiatric or medical problems that preclude them from having surgery
  3. * Female patients that are pregnant or breastfeeding
  4. * Prisoners
  5. * Patients who are unwilling or unable to follow-up

Contacts and Locations

Study Contact

Tera Thigpin
CONTACT
3522652393
tera.thigpin@surgery.ufl.edu

Principal Investigator

Harvey Chim, MD
PRINCIPAL_INVESTIGATOR
University of Florida

Study Locations (Sites)

University of Florida
Gainesville, Florida, 32610
United States

Collaborators and Investigators

Sponsor: University of Florida

  • Harvey Chim, MD, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-21
Study Completion Date2027-05-17

Study Record Updates

Study Start Date2020-08-21
Study Completion Date2027-05-17

Terms related to this study

Additional Relevant MeSH Terms

  • Flexor Tendon