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OpenTrials
Completed

NCT Number: NCT05598801

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

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

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Key information

Conditions

Tendon Repair Fracture Repair Tenolysis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Austin Hand Group

Austin, Texas, 78746, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18-70 at the time of surgery
  • Patients undergoing hand/finger surgery, including tendon repair, fracture repair or tenolysis
  • 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

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

Treatment and study plan

VersaWrap

Device

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

Primary outcomes

  1. Number of participants diagnosed with post-operative tenolysis

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Research Source

Network

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 28, 2022
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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