Plastic and Reconstructive Surgery

Prospective randomized trial of Versawrap tendon protector for zone 2 flexor tendon injuries

Principal Investigator: Harvey Chim, MD

Study Description: Flexor tendon lacerations, particularly in the region of the finger are a difficult problem. The area where this occurs most frequently is in zone 2, the region between the distal palm and middle phalanx where the flexor digitorum superficialis and flexor digitorum profundus tendons are in close contact. Tendon adhesions are a major problem following repair and often result in decreased range of motion and poor outcomes even with the best rehabilitation protocols. As this is a difficult problem, surgeons around the country utilize different methods to optimize surgical outcomes; however, there is no national standard or consensus on the best method of treatment for these injuries.

The purpose of this study is to prospectively analyze outcomes between patients with zone 2 flexor tendon (Z2FT) injuries following repair, randomized to two groups. The first group will be the control, with no tendon wrap. The second group will have a VersaWrap Tendon Protector applied over the site of the tendon repair. This study will potentially result in improved outcomes for patients with flexor tendon injuries.

A Phase 2a, multicenter, randomized, patient and evaluator blinded, controlled study evaluating the safety and efficacy of NTX-001 compared to standard of care in the treatment of acute single transacted peripheral nerve injury occurring below the distal border of the brachial plexus requiring surgical repair

Principal Investigator: Harvey Chim, MD

Study Description: This is a multicenter, prospective randomized trial assessing the efficacy of a novel intervention incorporating axonal fusion for promoting nerve recovery after peripheral nerve injuries. More than 1.4 million traumatic peripheral nerve injuries (PNI) occur in the USA each year. Immediately after a PNI the patient experiences complete loss of sensation and function. Recovery after PNI is only possible by natural regrowth of axons from the proximal end of the nerve. The process is slow, with nerves growing about 1mm/ day and imperfect. Current standard of care for transected PNI involved surgical reattachment of the nerve stumps with microsutures, however this does not address degeneration of nerve beyond the point of injury. This trial aims to assess an intervention which may potentially prevent Wallerian degeneration, eliminating the period of total denervation, reducing the time to stable recovery and providing improved recovery for patients with PNI.

Please contact Tera Thigpin at 352.273.5670 or for more information about acute care surgery clinical trials.