Clinical trial NCT04322370: Prospective Randomized Blinded Trial of VersaWrap Tendon Protector for Zone 2 Flexor Tendon Injuries
Official title: Prospective Randomized Blinded Trial of VersaWrap Tendon Protector for Zone 2 Flexor Tendon Injuries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Flexor Tendon
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 VersaWrap Tendon Protector applied over the site of the tendon repair. VersaWrap is current SOC at UF.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Strickland modified Total Active Motion (TAM)
timeFrame: At 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Ellen Satteson, MD
role: PRINCIPAL_INVESTIGATOR
References: