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

NCT05598801 | Completed FDA Device

• 1 other identifier: VW-001- Version 02
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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

Conditions

Tendon Repair; Fracture Repair; Tenolysis

Outcome Measures

Primary Outcomes (1)

• Number of participants diagnosed with post-operative tenolysis

  6 months

Study Arms (1)

VersaWrap

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

Device: VersaWrap

Interventions

VersaWrap DEVICE

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

VersaWrap

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Research Source: lead

Study Sites (1)

Austin Hand Group

Austin, Texas, 78746, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: October 28, 2022
• Study Start: September 1, 2022
• Primary Completion: August 17, 2025
• Study Completion: August 17, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

US (1)