Adults aged 18-55 years who are undergoing a surgical procedure that will generate a large gap (3-10 cm) in peripheral nerve discontinuity (sensory, motor or mixed) that cannot be directly repaired with suturing Surgery
Conditions
Interventions
For adults aged 18-55 years who are undergoing a surgical procedure that will generate a large gap (3-10 cm) peripheral nerve discontinuity (sensory, motor or mixed) that cannot be directly repaired w
Sponsors
Newrotex Limited
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the trial 2. Between 18 and 55 years of age 3. Patient requires surgery that would require planned transection of a peripheral nerve, generating a “large gap” defect between 3 and 10 cm (e.g. nerve biopsy, autograft donor or tumour excision) 4. Transected nerve can be reconstructed at same operation as defect created 5. Sufficient distal skin sensation or measurable motor function present for transected nerve to be able to record effect of transection and subsequent recovery 6. In the Investigator’s opinion, is able and willing to comply with all trial requirements 7. Willing to attend sufficient follow-up assessments to determine the outcomes of the repair and comply with site-specific postoperative care procedures
Exclusion criteria
Exclusion criteria: 1. Their medical history includes disorders known to affect the peripheral nervous system (e.g., diabetes mellitus, chronic heavy alcohol use, toxic nerve lesions, polyneuropathy) 2. Their presentation includes any additional injury that could compromise nerve regeneration (e.g., vascular insufficiency to the harvested lower limb) 3. They are known to have a condition, which the Investigator believes may make implementation/interpretation of the protocol or results difficult 4. They have had previous conditions of the affected area that could affect the healing of the actual nerve injury 5. They have been treated with immunosuppressive or antineoplastic agents within 30 days prior to the enrolment 6. Known to be HIV positive from their medical history 7. Participated in another clinical investigation using an investigational new drug or device within 30 days prior to enrolment into this investigation 8. Uncooperative or unsuitable subject (e.g., language barrier, strong suspicion of inability to adhere to follow-up schedule) 9. Suspected or documented allergy to silk 10. Patient is pregnant, lactating, or intends to become pregnant during the study. 11. Medical history of previous vein stripping procedures at the intended surgical site 12. Planned nerve to undergo transection has no clear sensory distribution or measurable motor function based on clinical knowledge and examination
Countries
Panama
Contacts
Public ContactAlex Woods
Outcome results
None listed