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

NCT ID: NCT05598801

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2025-08-17

Brief Summary

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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

Detailed Description

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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.

Conditions

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Tendon Repair Fracture Repair Tenolysis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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VersaWrap

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

VersaWrap

Intervention Type DEVICE

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

Interventions

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VersaWrap

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

Intervention Type DEVICE

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Research Source

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Austin Hand Group

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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VW-001- Version 02

Identifier Type: -

Identifier Source: org_study_id

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