VersaWrap for Flexor Tendon Injuries

Overseen By Stephan Alvarez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Allergies, Psychiatric problems, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: Immediate post-surgery

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments for Zone 2 flexor tendon injuries in the hand. One group will receive standard surgical repair, while the other will have a special protective wrap called VersaWrap applied over the repaired tendon. VersaWrap is already part of standard care at the University of Florida. The trial seeks adults who need surgery for a Zone 2 flexor tendon injury and do not have allergies to materials like alginate or hyaluronic acid. As an unphased trial, it offers patients the chance to contribute to medical research and potentially benefit from innovative treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the VersaWrap Tendon Protector is safe for flexor tendon injuries?

Research has shown that VersaWrap is generally safe and well-tolerated in tendon repair surgeries. The FDA has approved it for certain surgeries where the tendon isn't severely damaged, indicating its safety for these procedures.

In one study, 87% of patients who used VersaWrap after tendon repair achieved "Excellent" or "Good" recovery results. This suggests that most people healed well with few complications. Patients also reported low pain levels, with an average score of 1.3 out of 10, indicating that VersaWrap causes minimal discomfort.

These findings suggest that VersaWrap is a safe choice for tendon repair, with most patients experiencing good recovery and low pain. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard of care for flexor tendon injuries, which typically involves traditional surgical repair techniques, VersaWrap offers a novel approach by incorporating an advanced bioresorbable wrap during the surgery. This wrap is designed to enhance healing by reducing scar tissue formation, which can improve the overall function and recovery time for the injured tendon. Researchers are excited about VersaWrap because it could potentially lead to better outcomes for patients, offering quicker and more complete recovery compared to conventional methods.

What evidence suggests that the VersaWrap Tendon Protector is effective for flexor tendon injuries?

This trial will compare the VersaWrap Tendon Protector with the standard surgical procedure for flexor tendon repair. Research has shown that the VersaWrap Tendon Protector may aid recovery from flexor tendon injuries. In one study, 87% of patients using VersaWrap achieved "Excellent" or "Good" recovery after tendon repair. Approximately 4.6 months post-surgery, patients could actively move their tendons 88.8% of the normal range and passively move them 94.3%. Their overall function returned to 87.7%. These results suggest that VersaWrap might support healing and improve movement more effectively than standard care. ^{1 2 4 6 7}

Who Is on the Research Team?

Ellen Satteson, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

Adults with a zone 2 flexor tendon injury needing surgery can join this trial. They must be able to follow up post-surgery. People allergic to certain polysaccharides, those with serious medical or psychiatric issues, pregnant or breastfeeding women, and prisoners are excluded.

Inclusion Criteria

I need surgery for a tendon injury in my hand.

Exclusion Criteria

Patients with a sensitivity or allergy to polysaccharides alginate, hyaluronic acid, or citrate

I cannot have surgery due to my psychiatric or medical condition.

I am willing and able to follow up with my doctor's appointments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Zone 2 flexor tendon repair with or without VersaWrap Tendon Protector

Immediate post-surgery

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations at 2 weeks, 6 weeks, and 3 months post-surgery

3 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Standard of Care Surgical Procedure
• VersaWrap Treatment

Trial Overview The study is testing if using VersaWrap Tendon Protector on repaired tendons leads to better outcomes than the standard surgical procedure without it. Participants will be randomly assigned to either receive VersaWrap or not after their tendon repair surgery.

How Is the Trial Designed?

Group I: Group A Active Control 2 Interventions

VersaWrap Treatment Arm- Zone 2 flexor tendon repair with the use of VersaWrap

Group II: Group B Active Control 1 Intervention

Standard of Care Treatment Arm- Zone 2 flexor tendon repair

Standard of Care Surgical Procedure is already approved in United States, European Union for the following indications:

Approved in United States as Standard of Care Surgical Procedure for Flexor Tendon Repair for:

• Flexor tendon injuries
• Zone 2 flexor tendon injuries

Approved in European Union as Flexor Tendon Repair Surgery for:

• Flexor tendon injuries
• Hand injuries
• Finger injuries

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

For successful flexor tendon repair, using a multistrand core suture with at least 4 strands is essential to enable active range of motion in the finger or thumb after surgery.

Incorporating an epitendinous suture can enhance the strength of the tendon repair, and following a careful post-operative therapy regimen is crucial for optimal recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based flexor tendon repair. Mehling, IM., Arsalan-Werner, A., Sauerbier, M.[2014]

Over the past 30 years, advancements in multistrand suture repair techniques and rehabilitation protocols have significantly improved the treatment outcomes for intrasynovial flexor tendon injuries.

Current treatment protocols emphasize a strong initial repair followed by passive motion rehabilitation, which is supported by recent clinical and scientific findings on tendon behavior and grafts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flexor tendon repair and rehabilitation: state of the art in 2002. Boyer, MI., Strickland, JW., Engles, D., et al.[2006]

Flexor tendon surgery is complex and requires a deep understanding of tendon anatomy and injury status, as well as technical skill in various repair techniques to restore function effectively.

Advancements in flexor tendon surgery are expected to improve outcomes, allowing patients to regain nearly full function of their digits after tendon injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flexor tendon injuries. Part 5. Flexor tenolysis, rehabilitation and results. Strickland, JW.[2008]

The authors suggest that improving flexor tendon repair can be achieved through the use of simpler yet stronger sutures, proper venting of the pulley system, and early rehabilitation, which may enhance recovery outcomes.

There is a need for ongoing research to better understand and modify adhesions that can form after tendon repair surgery, as these can impact the overall success of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary flexor tendon surgery: the search for a perfect result. Elliot, D., Giesen, T.[2013]

Recent advancements in flexor tendon surgery, including slightly tensioned multistrand repairs and early active motion, have led to improved patient outcomes, particularly for challenging Zone 2 injuries.

The use of wide awake local anesthesia no tourniquet (WALANT) during surgery allows for intraoperative active movement, which can be tailored to individual patient needs, enhancing the effectiveness of the repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Getting Better Results in Flexor Tendon Surgery and Therapy. Ayhan, E., Tuna, Z., Oksuz, C.[2021]

Recent advancements in the understanding of injury repair mechanisms have led to improved techniques for treating zone 2 flexor injuries, enhancing patient outcomes.

New suture methods now allow for immediate active flexion post-surgery, which may improve recovery times compared to traditional methods that rely on passive flexion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Rehabilitation after flexor tendon surgery]. Hahn, P., Jacobs, C., Müller-Zimmermann, A.[2006]

Flexor tendon injuries, often caused by penetrating trauma, require surgical repair for complete lacerations, and various techniques are available for effective repair depending on the tendon zone.

Postoperative rehabilitation is crucial for successful recovery, with several rehabilitation protocols outlined to enhance outcomes after tendon repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Considerations for Flexor Tendon Repair: Timing and Choice of Repair Technique and Rehabilitation. Sasor, SE., Chung, KC.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11683011/

Evaluating the effect of VersaWrap tendon protector on ... In our cohort, 87% of patients achieved “Excellent” or “Good” functional status after flexor tendon repair with the VersaWrap tendon protector ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04322370

Study Details | NCT04322370 | Prospective Randomized ... The purpose of this study is to prospectively analyze outcomes between patients with Z2FT injuries following repair, randomized to two groups.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39737387/

Evaluating the effect of VersaWrap tendon protector on ... At a mean follow-up of 4.6 months, the mean active and passive ROM was 88.8% and 94.3%, respectively. Mean percent return of function was 87.7%.

4. ors.org ors.org/wp-content/uploads/AM24/Tendon/45.pdf

Evaluating the Effectiveness of Commercially Available ... Our data showed that around 42 days after flexor tendon repair, the Collagen-GAG sheet had significantly greater histological anti-adhesion properties compared ...

5. surgery.med.ufl.edu surgery.med.ufl.edu/clinical-trials/plastic-and-reconstructive-surgery-2/

Plastic and Reconstructive Surgery The purpose of this study is to prospectively analyze outcomes between patients with zone 2 flexor tendon (Z2FT) injuries following repair, randomized to two ...

6. ufhealth.org ufhealth.org/clinical-trials/versawrap

VersaWrap 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 ...

7. researchgate.net researchgate.net/figure/Outcomes-of-tendon-repairs-using-VersaWrap_tbl1_387515932

Outcomes of tendon repairs using VersaWrap. The average QuickDASH score was 30.7 (n = 44, range: 0-72.5), and the average pain score on the visual analogue scale (VAS) was 1.3/10 (n = 90, range: 0-8) ( ...