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

Flexor Tendon Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04322370
• Other study ID #: IRB201903272
• Secondary ID: OCR32662
• Status: Recruiting
• Phase: N/A
• Start date: August 21, 2020
• Est. completion date: May 17, 2027

Study information

• Verified date: June 2024
• Source: University of Florida
• Contact: Tera Thigpin
• Phone: 3522652393
• Email: tera.thigpin[@]surgery.ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: May 17, 2027
• Est. primary completion date: May 17, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Flexor Tendon
• Tendon Injuries

Intervention

Procedure:
• Standard of Care Surgical Procedure
Zone 2 Flexor Tendon surgical repair will be performed by the principal investigator per standard of care. The same technique of tendon repair will be performed for all patients.

Device:
• VersaWrap Treatment
is intended to manage and protect tendon injuries where there is no significant loss of tendon tissue

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Strickland modified Total Active Motion (TAM)	This is an objective assessment of range of motion of the finger (physiological parameter)	At 3 months