Can A New Nail Trephination Device Help Treat Nail Conditions?
- Volume 20 - Issue 11 - November 2007
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Emphasizing The Painless Nature Of The Procedure
A phase I study conducted at Brigham and Women’s Hospital (Boston) demonstrated that the mesoscissioning procedure causes virtually no pain.5 This study involved creating five microconduits of different depths in the great toenail in healthy volunteers using the PathFormer device. The microconduit depths ranged from the nail plate surface to the nail bed.
All 14 participants in the trial rated the pressure and pain sensation to be less than 3 (on a 1-10 scale with 10 indicating the highest degree of pain).5 This study also demonstrated that the depth control offered by the PathFormer is effective in a diverse population.
Facilitating More Effective Results With Subungual Hematomas And Onychomycosis
Subungual hematoma, commonly referred to as black toe, is an accumulation of blood in the space between the nail plate and the nail bed. Such injuries result from crushing of the nail against a hard surface and are common in long distance runners. The pressure generated from the accumulated blood can cause intense pain. Decompression of the hematoma can produce immediate relief. However, the decompression methods currently available can cause a significant amount of discomfort. Present treatment options include creating an opening in the affected nail with a heated paper clip or with an electrocautery device.
The trephination device can create one or more microconduits in the affected area to drain the pooled blood.6 Blood flows freely from the openings as soon as the cutter scissions through the nail plate. The procedure causes minimal, momentary discomfort with no side effects.
Onychomycosis is the most common disease of the nails and affects nearly 15 percent of the general population. Treatments include systemic therapy, topical treatment and nail avulsion by surgical or chemical means.7 Systemic therapy may lead to hepatotoxicity and drug interactions in patients receiving multiple medications.8 Topical medication to treat nail fungal infection is largely ineffective as it does not penetrate the nail plate well enough to reach the nail bed where the fungal organisms reside.
Microconduits provide an effective delivery route to the nail bed for the topical medications. Researchers conducted a double-blinded phase I clinical trial using the mesoscissioning technique in 28 patients with great toenail onychomycosis. Following the initial trephination, patients applied topical terbinafine (Lamisil, Novartis) cream or a placebo to the affected toenail twice daily for 24 weeks. Preliminary results suggest that nail trephination aids in medication delivery to the nail bed with 71 percent of patients showing improvement in clinical assessment in comparison to 28 percent in the placebo group.9
The transungual microconduits created by the PathFormer are less than 0.5 mm in diameter and are inconspicuous. The microscopic size of these openings also limit potential for infection or structural deformity of the nail. All the participants in a phase I trial agreed that the mesoscissioning procedure is painless and minimally invasive. The preoperative and operative procedures for creating these microconduits are simple and rapid, and physicians can easily perform them in the office.