Evaluate the Reconstruction of Digital Nerve Defects in Humans Using an Implanted Silk Nerve Guide

Study Overview
=================
Brief Summary
-----------------
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).

Detailed Description
-----------------
This is a pre-market, monocentre, first-in-human pilot on adult patients with digital nerve defects. Category C clinical trial, medical devices. The study will be performed in Switzerland. SilkBridge is a biocompatible silk fibroin-based scaffold, which recruits the patients' own cells to remodel or regenerate the nerve, without pre-seeding of the scaffold nor biological/chemical treatments. SilkBridge will provide surgeons with an implant with unique features, such as easy suturability, full biocompatibility and specific biomimetic properties that enhance cells adhesion and integration of the device with the surrounding tissue. The study will have a 12 months and 1 week duration per patient, including the follow-up period, and with an expected enrollment period of 15 months. The study will evaluate 15 adult patients, aged 18-65 years, diagnosed with digital nerve defects (> 5 mm gap) in whom surgical repair may not allow direct suture.

Official Title
-----------------
A Pilot Study to Evaluate the Reconstruction of Digital Nerve Defects in Humans Using an Implanted Silk Nerve Guide

Conditions
-----------------
Peripheral Nerve Injury Digital Nerve Hand

Intervention / Treatment
-----------------
* Device: SilkBridge


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open Label Monocentre Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SilkBridge treatment<br>Surgery for digital nerve reconstruction with SilkBridge | Device: SilkBridge<br>* SilkBridge is a biocompatible silk fibroin-based scaffold, which recruits the patients' own cells to remodel or regenerate the nerve, without pre-seeding of the scaffold nor biological/chemical treatments.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
peripheral nerve injury, nerve guide, silk fibroin, silk, nerve regeneration