RECON: Evaluating a Nerve Bridging Material (Avance® Nerve Graft) in Surgical Repair of Hand Nerves

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Age:
18-65
Gender:
Any
Healthy Volunteers:
No
Keywords:
Avance Nerve Graft, RECON, Nerve Discontinuities, nerve injury, Nerve Cuff, hand nerve, digital nerve, nerve, hand
Type:
comparative device study
Target:
10 Participants
Description
Many cut nerves can be repaired by sewing the two nerve ends back together. However, if the gap between the two nerves is too large, a bridging material is required to join the two nerve ends. The purpose of this study is to test the safety and effectiveness of a nerve bridging material in repairing hand nerve injuries. Two commercial nerve bridging materials are being compared. Their names are NeuraGen® Nerve Guide and Avance® Nerve Graft.

The NeuraGen® Nerve Guide acts as a tunnel made of collagen connecting your two damaged nerve endings. The tunnel creates a pathway which guides the nerves from one side of the tunnel to grow and rejoin with the nerves on the other side.

The Avance® Nerve Graft acts as a scaffold. Made from materials similar to those that comprise the nerves in your body. The scaffold will support the growth of your nerves across the gap between your damaged nerves.

In this trial, you will be receiving surgery to treat the nerve injury in your hand. You will be receiving either the NeuraGen® Nerve Guide or the Avance® Nerve Graft as your treatment.
This study requires
- Hand nerve repair surgery

- Follow-up visits in which you will have your hand evaluated to see how it is healing

- Questionnaires asking you to rank your satisfaction with the treatment you received
Who can participate?
Adults, 18 to 65 years of age requiring surgical hand nerve injury repair.
Benefits and risks of participating
You may regain some or all of the function of your damaged nerve. There are risks associated with every surgical procedure, such as the risk of anesthesia, bleeding, and infection. Risks and potential benefits will be discussed with you during the consent process.
Compensation
A $40 Visa gift card will be given to each time you attend your five follow up visits.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for up to twelve (12) months. You will have seven (7) scheduled study visits, including a screening, operative day, and 5 follow-up visits.
Contact
JoAnna Ramirez