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

ConditionFlexor Tendon

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-99

SponsorUniversity of Florida

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Standard of Care Surgical Procedure
Procedure/Surgery
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.
VersaWrap Treatment
Device
is intended to manage and protect tendon injuries where there is no significant loss of tendon tissue

Treatment groups

42 Participants

are divided into 2 treatment groups

Group A: Group AActive comparator 2 interventions

Group B: Group BActive comparator 1 intervention

Trial outcomes

Primary outcomes

Strickland modified Total Active Motion (TAM)

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

Time frame

At 3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Florida

Lead sponsor

Source ClinicalTrials.gov

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