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

Silk Biomaterials

Status

Unknown

Conditions

Peripheral Nerve Injury Digital Nerve Hand

Treatments

Device: SilkBridge

Study type

Interventional

Funder types

Industry

Identifiers

NCT03673449

SB_DND-01/2018

Details and patient eligibility

About

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).

Full 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.

Enrollment

4 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)