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CompletedNCT05598801Updated Sep 5, 2025

A Single-center, Prospective, Clinical Study of VersaWrap Utilization in the Hand

An observational study in Tendon Repair, Fracture Repair and Tenolysis, sponsored by Research Source. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-05.

Sponsored by Research Source · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
17
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the efficacy on the use of VersaWrap® in surgery of the hand/fingers, including tendon repair, fracture repair, or tenolysis of the hand/fingers. VersaWrap is designed to allow tendon gliding and to protect tendon gliding postoperatively

Read the detailed description

This is a prospective, post-market, observational, single center study evaluating the use of VersaWrap. Patients identified by the Investigator in his practice as needing surgery of the hand/fingers and meeting all the inclusion and none of the exclusion. Patients will consent to participating in the study, prior to any study procedures.

02

Conditions studied

  • Tendon Repair
  • Fracture Repair
  • Tenolysis
03

In context

Lead sponsor

Research Source is the lead sponsor of 8 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients who meet the following inclusion criteria and none of the exclusion criteria will be enrolled in the study. A patient is considered enrolled upon placement of the VersaWrap during the surgical procedure. If the surgeon decides intra-operatively not to utilize the VersaWrap, the patient will be considered a screen failure.

Inclusion criteria

  1. Patients aged 18-70 at the time of surgery
  2. Patients undergoing hand/finger surgery, including tendon repair, fracture repair or tenolysis
  3. Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule, study requirements with a signed informed consent with a study collaborator present at the time of signing to ensure compliance.

Exclusion criteria

Exclusion Criteria:

  1. Non-English speaking
  2. Known allergy or sensitivity to citrate, alginate or hyaluronate
  3. Pregnant or breastfeeding
  4. Currently a prisoner
  5. Patient has any condition, that in the opinion of the Investigator, would prohibit the patient from complying with the protocol
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
17 participants (actual)
Patient registry
No

Groups and cohorts

  • VersaWrap

    All enrolled patients will received VersaWrap applied prior to surgical closure on the affected tendon.

    Device: VersaWrap

Interventions

  • DeviceVersaWrap

    VersaWrap is applied to the affected tendon to allow post-operative gliding.

06

What researchers measure

Primary outcomes

  1. Number of participants diagnosed with post-operative tenolysis

    Time frame: 6 months

07

Study locations

1 site
  • Austin Hand Group
    Austin, Texas 78746, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05598801
Lead sponsor
Research Source
Responsible party
Sponsor
First posted
Oct 28, 2022
Start date
Sep 1, 2022
Primary completion
Aug 17, 2025
Completion
Aug 17, 2025
Last update
Sep 5, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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