Flexor TendonNCT04322370
Prospective Randomized Blinded Trial of VersaWrap Tendon Protector for Zone 2 Flexor Tendon Injuries
A study testing VersaWrap Treatment in people with Flexor Tendon, run by University of Florida at 1 site in United States.
Trial summary
To 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. VersaWrap is current SOC at UF. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Flexor Tendon
- What is being tested?
- VersaWrap Treatment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2020to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients presenting to the plastic surgery service with a zone 2 flexor tendon injury requiring surgical repair
Who cannot join
- Patients with a sensitivity or allergy to polysaccharides alginate, hyaluronic acid, or citrate
- 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
Trial locations and contacts
1 site in 1 country.
About this study
To 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. VersaWrap is current SOC at UF.
Read the detailed description
VersaWrap Tendon Protector is intended to manage and protect tendon injuries where there is no significant loss of tendon tissue. It functions by separating the healing tendon from surrounding tissues to facilitate tendon gliding and tendon healing. VersaWrap can be placed on, over, or around flexor tendons and remains in place until healing is complete and then is bioresorbed. VersaWrap is FDA cleared for the use in procedures where there is no significant loss of tendon tissue and is currently one of the standard of care treatments used for this injury at UF Health.
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
- Flexor Tendon
- Being tested
- Standard of Care Surgical Procedure, VersaWrap Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care Surgical ProcedureProcedure or surgery
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 TreatmentDevice
is intended to manage and protect tendon injuries where there is no significant loss of tendon tissue
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | VersaWrap Treatment Arm- Zone 2 flexor tendon repair with the use of VersaWrap Receives: Procedure: Standard of Care Surgical Procedure; Device: VersaWrap Treatment |
| Group B | Active comparator | Standard of Care Treatment Arm- Zone 2 flexor tendon repair Receives: Procedure: Standard of Care Surgical Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strickland modified Total Active Motion (TAM)
This is an objective assessment of range of motion of the finger (physiological parameter)
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start21 Aug 2020
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexor TendonStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellen Satteson, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322370
- Sponsor's protocol ID
- IRB201903272
- Other IDs
- OCR32662
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2020
- Last updated
- 31 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Blinded Trial of VersaWrap Tendon Protector for Zone 2 Flexor Tendon Injuries
- ClinicalTrials.gov ID
- NCT04322370
- Acronym / sponsor ID
- IRB201903272
- Conditions
- Flexor Tendon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 21 Aug 2020 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To 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. VersaWrap is current SOC at UF.
Detailed description
VersaWrap Tendon Protector is intended to manage and protect tendon injuries where there is no significant loss of tendon tissue. It functions by separating the healing tendon from surrounding tissues to facilitate tendon gliding and tendon healing. VersaWrap can be placed on, over, or around flexor tendons and remains in place until healing is complete and then is bioresorbed. VersaWrap is FDA cleared for the use in procedures where there is no significant loss of tendon tissue and is currently one of the standard of care treatments used for this injury at UF Health.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: Standard of Care Surgical Procedure, Device: VersaWrap TreatmentVersaWrap Treatment Arm- Zone 2 flexor tendon repair with the use of VersaWrap |
| Group B | Active comparator | Procedure: Standard of Care Surgical ProcedureStandard of Care Treatment Arm- Zone 2 flexor tendon repair |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients presenting to the plastic surgery service with a zone 2 flexor tendon injury requiring surgical repair
Key exclusion criteria (5 listed)
- Patients with a sensitivity or allergy to polysaccharides alginate, hyaluronic acid, or citrate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care Surgical ProcedureZone 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. | Procedure or surgery | Group A, Group B |
| VersaWrap Treatmentis intended to manage and protect tendon injuries where there is no significant loss of tendon tissue | Device | Group A |
Primary outcome
Strickland modified Total Active Motion (TAM)
Time frame: At 3 months
This is an objective assessment of range of motion of the finger (physiological parameter)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Flexor Tendon
Not yet recruiting
Study Evaluating the Safety and Efficacy of the TMChM Prosthesis in the Treatment of People With Chronic Flexor Tendon Fingers Injuries
Tendon Injuries
Recruiting
Ultrasound-Guided Repeated Saline Injections to Prevent and Treat Tendon Adhesions After Hand Tendon Repair
Tendon Adhesion, Zone II Flexor Tendon Injury
Recruiting
Virtual Reality Combined With Active Mobilization Post Flexor Tendon Repair
Flexor Tendon Injury
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Effects of Different Wrist Positions in Dorsal Blocking Orthoses After Flexor Tendon Repair
Flexor Tendon Injury, Tendon Injury - Hand
Recruiting
Registry-randomized Comparison of Rehabilitation Regimens After Flexor Tendon Injury in the Thumb
Flexor Tendon Injury, Rehabilitation Program
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Satteson, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VersaWrap Treatment in people with Flexor Tendon, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strickland modified Total Active Motion (TAM) (time frame: At 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.