Evaluating the VersaWrap Tendon Protector for flexor tendon injuries
Prospective Randomized Blinded Trial of VersaWrap Tendon Protector for Zone 2 Flexor Tendon Injuries
This study tests if using the VersaWrap Tendon Protector after surgery helps people with flexor tendon injuries heal better compared to standard care without it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT04322370 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare outcomes in patients with zone 2 flexor tendon injuries after surgical repair, by randomly assigning them to two groups. One group will receive the standard care without any tendon wrap, while the other group will have the VersaWrap Tendon Protector applied to the repair site. The VersaWrap is designed to protect and facilitate healing of the tendon by separating it from surrounding tissues. Outcomes will be assessed during routine post-operative visits at specified intervals to evaluate the effectiveness of the treatment.
Who should consider this trial
Good fit: Ideal candidates are adult patients with zone 2 flexor tendon injuries requiring surgical repair.
Not a fit: Patients with allergies to the materials used in the VersaWrap or those with significant medical issues that prevent surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve healing outcomes and reduce complications associated with flexor tendon injuries.
How similar studies have performed: While the use of tendon protectors is established, this specific application of the VersaWrap is being evaluated for its effectiveness, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients presenting to the plastic surgery service with a zone 2 flexor tendon injury requiring surgical repair Exclusion Criteria: * 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
Where this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Ellen Satteson, MD — University of Florida
- Study coordinator: Stephan Alvarez
- Email: stephan.alvarez@surgery.ufl.edu
- Phone: 352-294-5687
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.