NCT04322370

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

August 21, 2020

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

July 31, 2026

Status Verified

March 1, 2026

Enrollment Period

5.6 years

First QC Date

March 24, 2020

Last Update Submit

July 29, 2026

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 ProcedureDevice: 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 ProcedurePROCEDURE

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 AGroup B
VersaWrap TreatmentDEVICE

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

Group A

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Study Officials

  • Ellen Satteson, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

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

March 31, 2026

Study Completion

March 31, 2026

Last Updated

July 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)