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

University of Florida

Status: Enrolling

Conditions: Flexor Tendon

Treatments: Procedure: Standard of Care Surgical Procedure; Device: VersaWrap Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04322370

IRB201903272

OCR32662 (Other Identifier)

Details and patient eligibility

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.

Full 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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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 having surgery
  • Female patients that are pregnant or breastfeeding
  • Prisoners
  • Patients who are unwilling or unable to follow-up

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups

Group A

Active Comparator group

Description:

VersaWrap Treatment Arm- Zone 2 flexor tendon repair with the use of VersaWrap

Treatment:

Device: VersaWrap Treatment

Procedure: Standard of Care Surgical Procedure

Group B

Active Comparator group

Description:

Standard of Care Treatment Arm- Zone 2 flexor tendon repair

Treatment:

Procedure: Standard of Care Surgical Procedure