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

• Conditions: Tendon Repair; Fracture Repair; Tenolysis
• Interventions: Device: VersaWrap

• Registration Number: NCT05598801
• Lead Sponsor: Research Source

Brief 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

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.

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2022-10-25
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-28
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of participants diagnosed with post-operative tenolysis	6 months

Trial Locations

Locations (1)

Austin Hand Group; 🇺🇸 Austin, Texas, United States