Peripheral Nerve Injury Digital Nerve Hand Clinical Trial
Official title:
A Pilot Study to Evaluate the Reconstruction of Digital Nerve Defects in Humans Using an Implanted Silk Nerve Guide
| Verified date | March 2020 |
| Source | Silk Biomaterials srl |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The goal of this study is to ascertain the feasibility and safety of the procedure using SilkBridge - a biocompatible silk fibroin-based scaffold - for the regeneration of sensory nerve fibres and follow it up together with the reinnervation of the target organs (sensory receptors in the skin).
| Status | Active, not recruiting |
| Enrollment | 4 |
| Est. completion date | March 2021 |
| Est. primary completion date | March 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - male & female patients between 18 and 65 years of age - a traumatic injury or a post-traumatic neuroma of a digital nerve on the palmar side of the hand, between the metacarpophalangeal joint and the distal interphalangeal joint - single lesion per finger - nerve defect of >5mm - nerve treatment initiated within 24 months after nerve injury - signed informed consent Exclusion Criteria: - disorders known to affect the peripheral nervous system, such as, but not only, diabetes mellitus, chronic heavy alcohol use, or toxic nerve lesions, or any polyneuropathy - an additional injury that could compromise nerve regeneration - clinically significant (as defined by the investigator) renal, hepatic, cardiac, endocrine, metabolic, hematologic, autoimmune, or any systemic disease, which may make implementation/interpretation of the protocol or results difficult - previous conditions of the hand that could affect the healing of the actual nerve injury - complete amputation injury - extensive crush injury - grossly contaminated wound - receiving immunosuppressive or antineoplastic agents within 30 days prior to the enrolment - known to be HIV positive - known pregnant and lactating females - participated in another clinical investigation using an investigational new drug or device (or in the present study) within 30 days prior to enrolment into this investigation - uncooperative or unsuitable, e.g. language problems or a suspicion to be unable to attend follow up appointments, for completion of the investigation - absence of a healthy opposite finger - suspected allergy to silk - need of emergency surgery (within 24 hours from injury) |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Klinik für Plastische Chirurgie und Handchirurgie - UniversitätsSpital Zürich | Zürich |
| Lead Sponsor | Collaborator |
|---|---|
| Silk Biomaterials srl |
Switzerland,
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* Note: There are 11 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety of SilkBridge | Assess type and severity of adverse device effects related to SilkBridge and surgical procedure throughout the follow-up period | 12 months | |
| Secondary | Performance - assess at each study visit versus baseline | Sensory recovery after nerve reconstruction by static and moving 2-point discrimination and Semmes-Weinstein monofilament testing Pain evaluation via a visual analog scale (VAS: scale where patient has to specify level of pain by indicating a position along a continuous line between two end-points (0 - 10). 0 indicates no pain while 10 represents the highest level.) | 12 months | |
| Secondary | Performance - assess at V5 and at last visit versus opposite control finger | Sensory recovery by static and moving 2-point discrimination and Semmes-Weinstein monofilament testing | 6 and 12 months | |
| Secondary | Performance - assess at the last visit | Patient's satisfaction through the Patient Global Impression of Change (PGIC) questionnaire (Patient has to describe the change (if any) in activity limitations, symptoms, emotions and overall quality of life, in relation to its painful condition. 0 value represent no change, 7 a considerable improvement). | 12 months |