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

NCT04322370 | Recruiting FDA Device

• 2 other identifiers: IRB201903272OCR32662
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Flexor Tendon

Outcome Measures

Primary Outcomes (1)

• Strickland modified Total Active Motion (TAM)

  This is an objective assessment of range of motion of the finger (physiological parameter)

  At 3 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

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

Group B

ACTIVE COMPARATOR

Standard of Care Treatment Arm- Zone 2 flexor tendon repair

Procedure: Standard of Care Surgical Procedure

Interventions

Standard of Care Surgical Procedure 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.

Group A; Group B

VersaWrap Treatment DEVICE

is intended to manage and protect tendon injuries where there is no significant loss of tendon tissue

Group A

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

Study Officials

• Ellen Satteson, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephan Alvarez

CONTACT

352-294-5687; stephan.alvarez@surgery.ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The Occupational hand therapists will be blinded to the use of VersaWrap.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: March 26, 2020
• Study Start: August 21, 2020
• Primary Completion (Estimated): May 17, 2027
• Study Completion (Estimated): May 17, 2027
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)