TISSIUM's Nerve Coaptation Device First-in-Human Clinical Trial

Inclusion criteria

• Patient undergoing a repair of a proper digital nerve of the hand;
• 100% transection injury to the nerve under repair;
• Gap closure between the nerve ends can be achieved by flexion of the extremity without excessive tension;
• Clean surgical wound with sufficient healthy soft tissue that enables primary closure without adjunctive soft tissue procedures;
• Patient willing and able to provide a signed Patient Informed Consent Form;
• Patient willing and able to follow the study instructions and likely to complete all required study procedures and visits.

Exclusion criteria

• Patient has a known allergy to the constituent polymer of the investigational device;
• Patient has a documented diagnosis of peripheral neuropathy;
• Patient has a history of neuropathic pain;
• Patient has a history of injury to the nerve being studied;
• Patient has is missing the contralateral digit or with a history of injury to the contralateral digit (comparison control area);
• Patient is pregnant or nursing
• Any patient with a diagnosis of type 1 Diabetes Mellitus;