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VersaWrap for Flexor Tendon Injuries

N/A

Recruiting

Led By Harvey Chim, MD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 3 months

Awards & highlights

Study Summary

This trial will compare outcomes between patients with tendon injuries who have a tendon wrap (VersaWrap) and those who don't.

Who is the study for?

Adults with a zone 2 flexor tendon injury needing surgery can join this trial. They must be able to follow up post-surgery. People allergic to certain polysaccharides, those with serious medical or psychiatric issues, pregnant or breastfeeding women, and prisoners are excluded.Check my eligibility

What is being tested?

The study is testing if using VersaWrap Tendon Protector on repaired tendons leads to better outcomes than the standard surgical procedure without it. Participants will be randomly assigned to either receive VersaWrap or not after their tendon repair surgery.See study design

What are the potential side effects?

Since VersaWrap is part of the current standard of care at UF, side effects may be minimal but could include reactions at the site of application for those sensitive to its components like alginate, hyaluronic acid, or citrate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I need surgery for a tendon injury in my hand.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Strickland modified Total Active Motion (TAM)

Trial Design

2Treatment groups

Active Control

Group I: Group AActive Control2 Interventions

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

Group II: Group BActive Control1 Intervention

Standard of Care Treatment Arm- Zone 2 flexor tendon repair

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,341 Previous Clinical Trials

715,625 Total Patients Enrolled

Harvey Chim, MDPrincipal InvestigatorUniversity of Florida

Media Library

Standard of Care Surgical Procedure Clinical Trial Eligibility Overview. Trial Name: NCT04322370 — N/A

Standard of Care Surgical Procedure 2023 Treatment Timeline for Medical Study. Trial Name: NCT04322370 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study open to participants aged 25 and older?

"This clinical trial welcomes adults aged 18 or older, up to and including the age of 99 years."

Answered by AI

What type of individuals is this clinical trial best suited for?

"This medical trial is presently enrolling 42 individuals, between 18 and 99 years of age, with a current flexor tendon injury located in zone 2. All participants must seek the treatment from Plastic Surgery Services to qualify for enrollment."

Answered by AI

Are there any spots still available to join this investigation?

"The most recent update on clinicaltrials.gov indicates that enrollment is open for this medical trial, which was initially posted in August 2020. The information has been refreshed as of July 2022."

Answered by AI

What is the capacity for participants in this clinical trial?

"Confirmed. Clinicaltrials.gov has the data to show that this clinical trial, which was initially advertised on August 21st of 2020, is currently recruiting patients. 42 participants need to be sourced from a single site for the study's completion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Prospective Randomized Blinded Trial of VersaWrap Tendon Protector for Zone 2 Flexor Tendon Injuries". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04322370.