A Pilot Study to Evaluate the Reconstruction of Digital Nerve Defects in Humans Using an Implanted Silk Nerve Guide
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 4
- Locations
- 2
- Primary Endpoint
- Safety of SilkBridge
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Safety of SilkBridge
Time Frame: 12 months
Assess type and severity of adverse device effects related to SilkBridge and surgical procedure throughout the follow-up period
Secondary Outcomes
- Performance - assess at the last visit(12 months)
- Performance - assess at each study visit versus baseline(12 months)
- Performance - assess at V5 and at last visit versus opposite control finger(6 and 12 months)