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

Research Source

Status: Completed

Conditions: Tendon Repair; Fracture Repair; Tenolysis

Treatments: Device: VersaWrap

Study type: Observational

Funder types: NETWORK

Identifiers

NCT05598801

VW-001- Version 02

Details and patient eligibility

About

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

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

17 participants in 1 patient group

VersaWrap

Description:

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

Treatment:

Device: VersaWrap