Skin BiopsyTechnique for

Cutaneous Nerve Evaluation

Johns Hopkins UniversityDepartment of Neurology

Biogen Idec 103NS201Neublastin Trial

Johns Hopkins Cutaneous Nerve Laboratory• First CLIA / JCAHO / CAP certified clinical lab for epidermal quantitation – 35,000+ biopsies processed• Validated direct measure of axonal integrity• Demonstrated that epidermal nerve fibers are lost early in PN disease• Therefore often more sensitive than nerve conduction• IGT (pre-diabetes), HIV infection, amyloid, idiopathic neuropathy, CIPN• Core Laboratory for over one dozen multicenter clinical trials• Developed efficient models of nerve regeneration using injury models• Efficient safety measure of potential toxicity

The following items will be supplied by the central laboratory for the skin punch biopsies: • Sterile disposable 3mm skin punch• Sterile disposable forceps• Sterile disposable scalpel• Zamboni’s fixative solution (individual pre-filled tubes)• Phosphate buffer (individual pre-filled tubes)• Cryoprotective solution (individual pre-filled tubes)• Sample vials • Requisition form• Parafilm (for securely sealing the sample vial)• Template for biopsy site locations (1 per subject) • Easy to follow reference sheet• Cooler shipping box and ice pack

Skin biopsy template

Skin biopsy

gets a bad

wrap…

This will only hurt a little…

Biopsy Supplies

Use of countertraction and single slice to obtain biopsy

Biopsy PrecautionsCheck with patient regarding allergies to lidocaine or adhesives

Do not biopsy distal to, or on surgical site or scar tissue

Do not stretch skin while performing punch biopsy

Do not grasp across the entire superficial dermis or any epidermis

Do not allow tissue to dry out at any time, place in fix immediately

Fix for 6-24 hrs in refrigerator-do not freeze!

Do not crush biopsy while screwing on tube cap

Carefully fill out all associated paperwork, double checking tubelabels and biopsy requisition forms!

PGP9.5 Immunohistochemistry

Dermis

Epidermis

Stratum corneum

Sensorynerves

All centers should evaluate their biopsies at the time of biopsy…

Crush artifact caused by forceps during biopsy

Do NOT place biopsies in dry tubes without fix!

Twist punch tool away from seam edge…

Busy lab needs your help with QC of specimens…

Details…