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

Last updated: March 12, 2025
Sponsor: University of Florida
Overall Status: Active - Recruiting

Phase

N/A

Condition

Tendon Injuries

Treatment

Standard of Care Surgical Procedure

VersaWrap Treatment

Clinical Study ID

NCT04322370
IRB201903272
OCR32662
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 havingsurgery

  • Female patients that are pregnant or breastfeeding

  • Prisoners

  • Patients who are unwilling or unable to follow-up

Study Design

Total Participants: 42
Treatment Group(s): 2
Primary Treatment: Standard of Care Surgical Procedure
Phase:
Study Start date:
August 21, 2020
Estimated Completion Date:
May 17, 2027

Study 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 to facilitate tendon gliding and tendon healing. VersaWrap can be placed on, over, or around flexor tendons and remains in place until healing is complete and then is bioresorbed. VersaWrap is FDA cleared for the use in procedures where there is no significant loss of tendon tissue and is currently one of the standard of care treatments used for this injury at UF Health.

VersaWrap Tendon Protector includes a bioresorbable hydrogel sheet and a wetting solution. The sheet is transparent, flexible, ultrathin, non-sided, and can be cut to the desired size. It is made of polysaccharides alginate and hyaluronic acid.

Tendon adhesions are a major problem following repair, particularly for zone 2 flexor tendon (Z2FT) lacerations. The purpose of this study is to prospectively 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. Outcomes will be evaluated during standard of care post-operative clinic visits at 2 (+/-10 days) weeks, 6 weeks (+/-2 weeks) and 3 months (+/- 1 month) following surgery. Data will be collected from standard of care measurements that include the following outcome measures that will be performed at each follow up visit: range of motion of the affected finger at different joints; total active motion (TAM) of the finger; Strickland modification of TAM (only including proximal interphalangeal (PIP); and distal interphalangeal (DIP) joints), as well as, DASH score and Michigan Hand Outcomes questionnaire. A measurement of grip strength will be obtained at the 3 month follow up visit. This is an important study as adhesions are a particularly serious problem following repair of Z2FT injuries, which can result in persistent finger stiffness and decreased range of motion reducing the quality of life.

Connect with a study center

  • University of Florida

    Gainesville, Florida 32610
    United States

    Active - Recruiting

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