Planimetric Post-hoc Analysis of Women With Onychomycosis from Tavaborole 5% Phase III Studies: Evidence of Greater Improvements in Patients With >50% Baseline Infection.

Women with onychomycosis may suffer more effects on their quality of life than men. There is limited female-specific data on the treatment of onychomycosis. Tavaborole is a topical treatment option for onychomycosis. This post-hoc study evaluated the nail plates of women using data from the tavaborole 5% Phase III studies at baseline and end of study for the areas of healthy nail and infected nail. Over 52 weeks (48-week treatment, 4-week follow up), women treated with tavaborole had an average 32% increase in healthy nail and 21% decrease in infected nail. Patients with baseline infection involving >50% of the nail plate had an average increase in percentage of unaffected nail surface area of 81% and a corresponding 51% decrease in infected nail. These analyses suggest that patients with the greatest toenail involvement at baseline had greater overall improvements than those who were less affected. This evaluation provides additional clinical guidance for treating women with onychomycosis using tavaborole. J Drugs Dermatol. 2018;17(2):168-172.

Comparison of tissue damage, cleansing and cross-contamination potential during wound cleansing via two methods: lavage and negative pressure wound therapy with instillation.

The use of lavage was compared to negative pressure wound therapy (NPWT) with instillation (NPWTi) to assess extent of soft tissue damage, debris removal and environmental cross-contamination susceptibility in three distinct models. Scanning electron microscopy in an ex vivo model showed increased visible tissue trauma from lavage treatment at low and high pressures versus NPWTi, with the degree of trauma relative to the pressure of the irrigant. These results were corroborated in granulating full-thickness excisional swine wounds coated with dextran solution to simulate wound debris. Both low-pressure lavage and NPWTi demonstrated effective cleansing in this model, reducing debris by >90%. However, using three-dimensional photography to evaluate tissue damage by measuring immediate tissue swelling (changes in wound volume and depth) showed significantly greater (P < 0.05) swelling in low-pressure lavage-treated wounds compared with NPWTi-treated wounds. Lastly, bench top wound models were inoculated with fluorescent bacterial particles to assess environmental cross-contamination potential and collected at measured distances after treatment with low-pressure lavage and NPWTi. No evidence of cross-contamination was found with NPWTi, whereas one-half of the particles became 'aerosolised' during low-pressure lavage (P < 0.05). Collectively, these studies demonstrate the effective wound cleansing capabilities of NPWTi without the tissue damage and environmental contamination associated with lavage.

Distribution assessment comparing continuous and periodic wound instillation in conjunction with negative pressure wound therapy using an agar-based model.

Negative pressure wound therapy (NPWT) is a widely accepted and effective treatment for various wound types, including complex wounds. Negative pressure with instillation was initially used as a gravity-fed system whereby reticulated, open-cell foam in the wound bed was periodically exposed to cycles of soaking with instillation solution followed by NPWT. Recent publications have alluded to positive outcomes with continuous instillation, where fluid is delivered simultaneously with negative pressure. To evaluate the distribution of instillation solutions to wound beds in conjunction with negative pressure, agar-based models were developed and exposed to coloured instillation solutions to identify exposure intensity via agar staining. This model allowed comparison of continuous- versus periodic-instillation therapy with negative pressure. Continuous instillation at a rate of 30 cc/hour with negative pressure showed isolated exposure of instillation fluid to wound beds in agar wound models with and without undermining and tunnelling. In contrast, periodic instillation illustrated uniform exposure of the additive to the entire wound bed including undermined and tunnel areas, with increased staining with each instillation cycle. These findings suggest that periodic instillation facilitates more uniform exposure throughout the wound, including tunnels and undermining, to instillation solutions, thereby providing therapy consistent with the clinician-ordered treatment.

Science supporting negative pressure wound therapy with instillation.

A new method (V.A.C.ULTA Therapy System, KCI USA, Inc., San Antonio, TX) combines the benefits of negative pressure wound therapy (NPWT; V.A.C. Therapy, KCI USA, Inc.) with regulated, periodic instillation of user-selected topical wound solutions (V.A.C. VeraFlo Therapy, KCI USA, Inc.). In simulated wound model studies comparing solution distribution using NPWT with and without a soak phase, the instillation soak phase allowed for uniform solution distribution across the wound bed, whereas continuous (no soak) irrigation resulted in uneven coverage. Additional in vitro work illustrated that bacterial particle aerosolisation during wound cleansing was significantly decreased using NPWT with instillation (NPWTi) versus commercially available low-pressure wound cleansers (P < 0·05). In porcine studies, NPWT with saline instillation induced 43% more granulation tissue versus NPWT (P < 0·05) and was as effective at wound cleansing as pulsed lavage. These studies have demonstrated that NPWTi may be an effective wound management therapy that provides both wound cleansing and NPWT benefits.