Clinical trial NCT03673449: Evaluate the Reconstruction of Digital Nerve Defects in Humans Using an Implanted Silk Nerve Guide
Official title: A Pilot Study to Evaluate the Reconstruction of Digital Nerve Defects in Humans Using an Implanted Silk Nerve Guide
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Nerve Injury Digital Nerve Hand
Keywords: peripheral nerve injury
nerve guide
silk fibroin
silk
nerve regeneration
Lead sponsor: Silk Biomaterials srl
Sponsor class: INDUSTRY
First posted: 2018-09-17
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open Label Monocentre Study
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Safety of SilkBridge
timeFrame: 12 months
Secondary outcomes:
measure: Performance - assess at each study visit versus baseline
timeFrame: 12 months
measure: Performance - assess at V5 and at last visit versus opposite control finger
timeFrame: 6 and 12 months
measure: Performance - assess at the last visit
timeFrame: 12 months
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Klinik für Plastische Chirurgie und Handchirurgie - UniversitätsSpital Zürich
Study officials:
affiliation: Klinik für Plastische Chirurgie und Handchirurgie - UniversitätsSpital Zürich
name: Maurizio Calcagni, MD
role: PRINCIPAL_INVESTIGATOR
References:
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