Prospective Randomized Blinded Trial of VersaWrap Tendon Protector for Zone 2 Flexor Tendon Injuries
NCT ID: NCT04322370
Last Updated: 2025-03-17
Study Results
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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RECRUITING
NA
42 participants
INTERVENTIONAL
2020-08-21
2027-05-17
Brief Summary
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Detailed Description
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VersaWrap Tendon Protector includes a bioresorbable hydrogel sheet and a wetting solution. The sheet is transparent, flexible, ultrathin, non-sided, and can be cut to the desired size. It is made of polysaccharides alginate and hyaluronic acid.
Tendon adhesions are a major problem following repair, particularly for zone 2 flexor tendon (Z2FT) lacerations. The purpose of this study is to prospectively analyze outcomes between patients with Z2FT injuries following repair, randomized to two groups. The first group will be the negative control, with no tendon wrap. The second group will have a VersaWrap Tendon Protector applied over the site of the tendon repair. Outcomes will be evaluated during standard of care post-operative clinic visits at 2 (+/-10 days) weeks, 6 weeks (+/-2 weeks) and 3 months (+/- 1 month) following surgery. Data will be collected from standard of care measurements that include the following outcome measures that will be performed at each follow up visit: range of motion of the affected finger at different joints; total active motion (TAM) of the finger; Strickland modification of TAM (only including proximal interphalangeal (PIP); and distal interphalangeal (DIP) joints), as well as, DASH score and Michigan Hand Outcomes questionnaire. A measurement of grip strength will be obtained at the 3 month follow up visit. This is an important study as adhesions are a particularly serious problem following repair of Z2FT injuries, which can result in persistent finger stiffness and decreased range of motion reducing the quality of life.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group A
VersaWrap Treatment Arm- Zone 2 flexor tendon repair with the use of VersaWrap
Standard of Care Surgical Procedure
Zone 2 Flexor Tendon surgical repair will be performed by the principal investigator per standard of care. The same technique of tendon repair will be performed for all patients.
VersaWrap Treatment
is intended to manage and protect tendon injuries where there is no significant loss of tendon tissue
Group B
Standard of Care Treatment Arm- Zone 2 flexor tendon repair
Standard of Care Surgical Procedure
Zone 2 Flexor Tendon surgical repair will be performed by the principal investigator per standard of care. The same technique of tendon repair will be performed for all patients.
Interventions
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Standard of Care Surgical Procedure
Zone 2 Flexor Tendon surgical repair will be performed by the principal investigator per standard of care. The same technique of tendon repair will be performed for all patients.
VersaWrap Treatment
is intended to manage and protect tendon injuries where there is no significant loss of tendon tissue
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with psychiatric or medical problems that preclude them from having surgery
* Female patients that are pregnant or breastfeeding
* Prisoners
* Patients who are unwilling or unable to follow-up
18 Years
99 Years
ALL
No
Sponsors
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University of Florida
OTHER
Responsible Party
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Principal Investigators
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Ellen Satteson, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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University of Florida
Gainesville, Florida, United States
Countries
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Central Contacts
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Other Identifiers
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OCR32662
Identifier Type: OTHER
Identifier Source: secondary_id
IRB201903272
Identifier Type: -
Identifier Source: org_study_id
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