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Lasers promising for onychomycosis treatment

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Lasers promising for onychomycosis treatment

DANA POINT, CALIF. – Lasers are playing a key role in the treatment of onychomycosis, with cure rates exceeding that of terbinafine in most cases, Dr. Jill S. Waibel said at a meeting sponsored by SkinCare Physicians and Northwestern University.

The development is welcome because currently approved treatment options are "suboptimal," said Dr. Waibel, a dermatologic surgeon with Miami (Fla.) Dermatology & Laser Institute. "There’s also a big need; 34% of diabetics have onychomycosis. They are at an increased risk of developing complications including foot ulcers and amputations. In addition, 50% of individuals over age 70 have onychomycosis. The market for treatment in the United States is $1.6 billion," she said.

Dr. Jill S. Waibel

All infectious agents can be killed by heat except prions, which makes laser therapy a promising option for onychomycosis, Dr. Waibel said. The mechanism of action is not fully understood, but she shared three hypotheses. The first is that water in the keratin of the nail absorbs the laser energy and creates nonspecific bulk heating, which denatures fungal organelles. The second hypothesis is that free radicals are created by the laser, and these kill the dermatophyte. The third hypothesis is that microscopic selective photothermolysis occurs in Trichophyton species that contain melanin in their cell walls. Microcavitation and acoustic shock waves are created, which decapsulate the spores. The mechanism of action "is probably a combination of all three," she speculated.

Before laser treatment, the patient’s toenails and the surrounding skin are cleaned, and photos are taken of the nails, Dr. Waibel said. The affected areas of nail are treated with randomly assigned laser or light wavelengths until a temperature of 46° C is reached.

"The thicker the nail, the more energy we put into it," Dr. Waibel said of the treatment. "For every 5° C increase in temperature, there is an exponential decrease in the time to cell death. When laser energy first strikes the nail bed, there is a rapid spike in temperature reaching the lower 60° C range," she explained. "If you’re at 60° C, it only takes about 6 seconds to kill the dermatophyte. At 70° C, that takes about 6 ms, so the lasers are getting to the temperature to kill the dermatophyte."

If the patient becomes uncomfortable, "We stop [the laser] and then return after a few seconds," Dr. Waibel said. "The average treatment time in my practice is 10 minutes. We give two to three treatments 1 week apart. The patients are very satisfied."

Post therapy, Dr. Waibel said she instructs patients to use antifungal spray in their shoes and to use fungal cream, "because you can get onychomycosis from having athlete’s foot." But, she added, "80% of toenail fungus comes from sleeping with your spouse. So if you treat the woman and you don’t treat the man, when they sleep at night and their toes touch, they’ll pass it back and forth."

In a prospective study conducted at the Dermatology & Laser Institute, 21 patients with positive dermatophytic periodic acid–Schiff (PAS) or positive cultures were randomly assigned to undergo treatment with one of three light source options: a 1,064-nm laser (at an energy fluence of 17 J/cm2, a pulse width of 0.3 ms, 5 pulses/sec, and a spot size of 3 mm); broadband light (with a SkinTyte filter delivered at 20° C for 30 seconds), or a 1,319-nm laser (at an energy fluence of 5 J/cm2, a pulse width of 10 ms, 5 pulses/sec, and a spot size of 3 mm). At 6 months’ follow-up, all but one patient in the 1,319-nm group was culture negative, "which is impressive," Dr. Waibel said. Oral terbinafine has a cure rate of only 50%, she noted.

In a separate retrospective study conducted at the center, 73 patients with onychomycosis were treated with the 1,064-nm laser with temperature feedback. Each patient completed three to four treatments 1 week apart. At 12 months’ follow-up, 67 patients were clear of infection, while 6 had a recurrent infection or had become newly infected. That’s still better than terbinafine, Dr. Waibel said.

She and her associates conducted a 12-month retrospective analysis of patients choosing therapy for positive culture/positive PAS during the year 2012. The patients were offered three treatment options: laser therapy, terbinafine, or no therapy. Nearly two-thirds (64%) chose laser, 20% chose terbinafine, and 16% chose no therapy.

Dr. Waibel disclosed that she is a speaker for and/or has received honoraria for equipment or clinical trials from numerous device and skin care product manufacturers.

[email protected]

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DANA POINT, CALIF. – Lasers are playing a key role in the treatment of onychomycosis, with cure rates exceeding that of terbinafine in most cases, Dr. Jill S. Waibel said at a meeting sponsored by SkinCare Physicians and Northwestern University.

The development is welcome because currently approved treatment options are "suboptimal," said Dr. Waibel, a dermatologic surgeon with Miami (Fla.) Dermatology & Laser Institute. "There’s also a big need; 34% of diabetics have onychomycosis. They are at an increased risk of developing complications including foot ulcers and amputations. In addition, 50% of individuals over age 70 have onychomycosis. The market for treatment in the United States is $1.6 billion," she said.

Dr. Jill S. Waibel

All infectious agents can be killed by heat except prions, which makes laser therapy a promising option for onychomycosis, Dr. Waibel said. The mechanism of action is not fully understood, but she shared three hypotheses. The first is that water in the keratin of the nail absorbs the laser energy and creates nonspecific bulk heating, which denatures fungal organelles. The second hypothesis is that free radicals are created by the laser, and these kill the dermatophyte. The third hypothesis is that microscopic selective photothermolysis occurs in Trichophyton species that contain melanin in their cell walls. Microcavitation and acoustic shock waves are created, which decapsulate the spores. The mechanism of action "is probably a combination of all three," she speculated.

Before laser treatment, the patient’s toenails and the surrounding skin are cleaned, and photos are taken of the nails, Dr. Waibel said. The affected areas of nail are treated with randomly assigned laser or light wavelengths until a temperature of 46° C is reached.

"The thicker the nail, the more energy we put into it," Dr. Waibel said of the treatment. "For every 5° C increase in temperature, there is an exponential decrease in the time to cell death. When laser energy first strikes the nail bed, there is a rapid spike in temperature reaching the lower 60° C range," she explained. "If you’re at 60° C, it only takes about 6 seconds to kill the dermatophyte. At 70° C, that takes about 6 ms, so the lasers are getting to the temperature to kill the dermatophyte."

If the patient becomes uncomfortable, "We stop [the laser] and then return after a few seconds," Dr. Waibel said. "The average treatment time in my practice is 10 minutes. We give two to three treatments 1 week apart. The patients are very satisfied."

Post therapy, Dr. Waibel said she instructs patients to use antifungal spray in their shoes and to use fungal cream, "because you can get onychomycosis from having athlete’s foot." But, she added, "80% of toenail fungus comes from sleeping with your spouse. So if you treat the woman and you don’t treat the man, when they sleep at night and their toes touch, they’ll pass it back and forth."

In a prospective study conducted at the Dermatology & Laser Institute, 21 patients with positive dermatophytic periodic acid–Schiff (PAS) or positive cultures were randomly assigned to undergo treatment with one of three light source options: a 1,064-nm laser (at an energy fluence of 17 J/cm2, a pulse width of 0.3 ms, 5 pulses/sec, and a spot size of 3 mm); broadband light (with a SkinTyte filter delivered at 20° C for 30 seconds), or a 1,319-nm laser (at an energy fluence of 5 J/cm2, a pulse width of 10 ms, 5 pulses/sec, and a spot size of 3 mm). At 6 months’ follow-up, all but one patient in the 1,319-nm group was culture negative, "which is impressive," Dr. Waibel said. Oral terbinafine has a cure rate of only 50%, she noted.

In a separate retrospective study conducted at the center, 73 patients with onychomycosis were treated with the 1,064-nm laser with temperature feedback. Each patient completed three to four treatments 1 week apart. At 12 months’ follow-up, 67 patients were clear of infection, while 6 had a recurrent infection or had become newly infected. That’s still better than terbinafine, Dr. Waibel said.

She and her associates conducted a 12-month retrospective analysis of patients choosing therapy for positive culture/positive PAS during the year 2012. The patients were offered three treatment options: laser therapy, terbinafine, or no therapy. Nearly two-thirds (64%) chose laser, 20% chose terbinafine, and 16% chose no therapy.

Dr. Waibel disclosed that she is a speaker for and/or has received honoraria for equipment or clinical trials from numerous device and skin care product manufacturers.

[email protected]

DANA POINT, CALIF. – Lasers are playing a key role in the treatment of onychomycosis, with cure rates exceeding that of terbinafine in most cases, Dr. Jill S. Waibel said at a meeting sponsored by SkinCare Physicians and Northwestern University.

The development is welcome because currently approved treatment options are "suboptimal," said Dr. Waibel, a dermatologic surgeon with Miami (Fla.) Dermatology & Laser Institute. "There’s also a big need; 34% of diabetics have onychomycosis. They are at an increased risk of developing complications including foot ulcers and amputations. In addition, 50% of individuals over age 70 have onychomycosis. The market for treatment in the United States is $1.6 billion," she said.

Dr. Jill S. Waibel

All infectious agents can be killed by heat except prions, which makes laser therapy a promising option for onychomycosis, Dr. Waibel said. The mechanism of action is not fully understood, but she shared three hypotheses. The first is that water in the keratin of the nail absorbs the laser energy and creates nonspecific bulk heating, which denatures fungal organelles. The second hypothesis is that free radicals are created by the laser, and these kill the dermatophyte. The third hypothesis is that microscopic selective photothermolysis occurs in Trichophyton species that contain melanin in their cell walls. Microcavitation and acoustic shock waves are created, which decapsulate the spores. The mechanism of action "is probably a combination of all three," she speculated.

Before laser treatment, the patient’s toenails and the surrounding skin are cleaned, and photos are taken of the nails, Dr. Waibel said. The affected areas of nail are treated with randomly assigned laser or light wavelengths until a temperature of 46° C is reached.

"The thicker the nail, the more energy we put into it," Dr. Waibel said of the treatment. "For every 5° C increase in temperature, there is an exponential decrease in the time to cell death. When laser energy first strikes the nail bed, there is a rapid spike in temperature reaching the lower 60° C range," she explained. "If you’re at 60° C, it only takes about 6 seconds to kill the dermatophyte. At 70° C, that takes about 6 ms, so the lasers are getting to the temperature to kill the dermatophyte."

If the patient becomes uncomfortable, "We stop [the laser] and then return after a few seconds," Dr. Waibel said. "The average treatment time in my practice is 10 minutes. We give two to three treatments 1 week apart. The patients are very satisfied."

Post therapy, Dr. Waibel said she instructs patients to use antifungal spray in their shoes and to use fungal cream, "because you can get onychomycosis from having athlete’s foot." But, she added, "80% of toenail fungus comes from sleeping with your spouse. So if you treat the woman and you don’t treat the man, when they sleep at night and their toes touch, they’ll pass it back and forth."

In a prospective study conducted at the Dermatology & Laser Institute, 21 patients with positive dermatophytic periodic acid–Schiff (PAS) or positive cultures were randomly assigned to undergo treatment with one of three light source options: a 1,064-nm laser (at an energy fluence of 17 J/cm2, a pulse width of 0.3 ms, 5 pulses/sec, and a spot size of 3 mm); broadband light (with a SkinTyte filter delivered at 20° C for 30 seconds), or a 1,319-nm laser (at an energy fluence of 5 J/cm2, a pulse width of 10 ms, 5 pulses/sec, and a spot size of 3 mm). At 6 months’ follow-up, all but one patient in the 1,319-nm group was culture negative, "which is impressive," Dr. Waibel said. Oral terbinafine has a cure rate of only 50%, she noted.

In a separate retrospective study conducted at the center, 73 patients with onychomycosis were treated with the 1,064-nm laser with temperature feedback. Each patient completed three to four treatments 1 week apart. At 12 months’ follow-up, 67 patients were clear of infection, while 6 had a recurrent infection or had become newly infected. That’s still better than terbinafine, Dr. Waibel said.

She and her associates conducted a 12-month retrospective analysis of patients choosing therapy for positive culture/positive PAS during the year 2012. The patients were offered three treatment options: laser therapy, terbinafine, or no therapy. Nearly two-thirds (64%) chose laser, 20% chose terbinafine, and 16% chose no therapy.

Dr. Waibel disclosed that she is a speaker for and/or has received honoraria for equipment or clinical trials from numerous device and skin care product manufacturers.

[email protected]

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EXPERT ANALYSIS FROM CONTROVERSIES AND CONVERSATIONS IN LASER AND COSMETIC SURGERY

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Nail complications of cancer therapies on the rise

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Nail complications of cancer therapies on the rise

NEW YORK – Nail complications are increasingly recognized as a problematic side effect of chemotherapies and biologic therapies for cancer patients.

In some cases these are cosmetic issues, but the side effects really do interfere with activities of daily living for many cancer patients, Dr. Patricia S. Myskowski, an attending dermatologist at Memorial Sloan Kettering Cancer Center, New York, reported at the American Academy of Dermatology summer meeting.

Dr. Patricia Myskowski

In a list of toxicities provided by the National Cancer Institute in 2006, only three categories of nail toxicities were listed, and these employed relatively vague descriptions, according to Dr. Myskowski. More recent summaries, including a literature review (J. Oncol. Pharm. Pract. 2009;15:143-55), have helped to classify and quantify nail complications as well as provide therapeutic guidance.

Taxanes, and specifically docetaxel, are "the worst offenders" of chemotherapies resulting in nails disorders, she said. More than 80% of patients treated with multiple cycles of docetaxel will develop some nail changes. Most are cosmetic reactions, such as depigmentation, but nearly one-third of patients have reactions that interfere with activities of daily living.

One of the most bothersome of these complications is subungual hematomas with hemopurulent discharge. In patients with nail infection, antibiotics may accelerate drainage and healing, but Dr. Myskowski suggested that this complication can be avoided by keeping the nails trimmed as short as possible.

Short nails are associated with a reduced risk of secondary infection, said Dr. Myskowski, who advised bacterial and fungal cultures when infection is suspected.

Biological therapies, particularly epidermal growth factor receptor (EGFR) inhibitors and tyrosine kinase inhibitors (TKIs), also are associated with a high rate of nail disorders, including paronychia, pyogenic granuloma, and infection. Although nail disorders are far less common than the characteristic rash associated with these agents, she cited one study suggesting a 12% incidence of symptomatic paronychia on EGFR inhibitors. Typically, nail complications emerge about 2 months after treatment is initiated.

To prevent paronychia associated with EGFR inhibitors, Dr. Myskowksi recommended following guidelines issued by the National Comprehensive Cancer Network (J. Natl. Compr. Canc. Netw. 2009;75:S5-S21).

Recommendations include avoiding frequent water immersion as well as contact with harsh chemicals. Applying petroleum jelly to the periungual soft tissue may be protective. In the event of nail infection, augmenting antibiotic therapy with topical therapies such as silver nitrate solution or white vinegar soaks may speed healing. In patients who have reinfections of toenails, disposing of shoes that may harbor bacteria sometimes resolves the problem.

Dr. Myskowski reported no financial disclosures relevant to her presentation.

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NEW YORK – Nail complications are increasingly recognized as a problematic side effect of chemotherapies and biologic therapies for cancer patients.

In some cases these are cosmetic issues, but the side effects really do interfere with activities of daily living for many cancer patients, Dr. Patricia S. Myskowski, an attending dermatologist at Memorial Sloan Kettering Cancer Center, New York, reported at the American Academy of Dermatology summer meeting.

Dr. Patricia Myskowski

In a list of toxicities provided by the National Cancer Institute in 2006, only three categories of nail toxicities were listed, and these employed relatively vague descriptions, according to Dr. Myskowski. More recent summaries, including a literature review (J. Oncol. Pharm. Pract. 2009;15:143-55), have helped to classify and quantify nail complications as well as provide therapeutic guidance.

Taxanes, and specifically docetaxel, are "the worst offenders" of chemotherapies resulting in nails disorders, she said. More than 80% of patients treated with multiple cycles of docetaxel will develop some nail changes. Most are cosmetic reactions, such as depigmentation, but nearly one-third of patients have reactions that interfere with activities of daily living.

One of the most bothersome of these complications is subungual hematomas with hemopurulent discharge. In patients with nail infection, antibiotics may accelerate drainage and healing, but Dr. Myskowski suggested that this complication can be avoided by keeping the nails trimmed as short as possible.

Short nails are associated with a reduced risk of secondary infection, said Dr. Myskowski, who advised bacterial and fungal cultures when infection is suspected.

Biological therapies, particularly epidermal growth factor receptor (EGFR) inhibitors and tyrosine kinase inhibitors (TKIs), also are associated with a high rate of nail disorders, including paronychia, pyogenic granuloma, and infection. Although nail disorders are far less common than the characteristic rash associated with these agents, she cited one study suggesting a 12% incidence of symptomatic paronychia on EGFR inhibitors. Typically, nail complications emerge about 2 months after treatment is initiated.

To prevent paronychia associated with EGFR inhibitors, Dr. Myskowksi recommended following guidelines issued by the National Comprehensive Cancer Network (J. Natl. Compr. Canc. Netw. 2009;75:S5-S21).

Recommendations include avoiding frequent water immersion as well as contact with harsh chemicals. Applying petroleum jelly to the periungual soft tissue may be protective. In the event of nail infection, augmenting antibiotic therapy with topical therapies such as silver nitrate solution or white vinegar soaks may speed healing. In patients who have reinfections of toenails, disposing of shoes that may harbor bacteria sometimes resolves the problem.

Dr. Myskowski reported no financial disclosures relevant to her presentation.

NEW YORK – Nail complications are increasingly recognized as a problematic side effect of chemotherapies and biologic therapies for cancer patients.

In some cases these are cosmetic issues, but the side effects really do interfere with activities of daily living for many cancer patients, Dr. Patricia S. Myskowski, an attending dermatologist at Memorial Sloan Kettering Cancer Center, New York, reported at the American Academy of Dermatology summer meeting.

Dr. Patricia Myskowski

In a list of toxicities provided by the National Cancer Institute in 2006, only three categories of nail toxicities were listed, and these employed relatively vague descriptions, according to Dr. Myskowski. More recent summaries, including a literature review (J. Oncol. Pharm. Pract. 2009;15:143-55), have helped to classify and quantify nail complications as well as provide therapeutic guidance.

Taxanes, and specifically docetaxel, are "the worst offenders" of chemotherapies resulting in nails disorders, she said. More than 80% of patients treated with multiple cycles of docetaxel will develop some nail changes. Most are cosmetic reactions, such as depigmentation, but nearly one-third of patients have reactions that interfere with activities of daily living.

One of the most bothersome of these complications is subungual hematomas with hemopurulent discharge. In patients with nail infection, antibiotics may accelerate drainage and healing, but Dr. Myskowski suggested that this complication can be avoided by keeping the nails trimmed as short as possible.

Short nails are associated with a reduced risk of secondary infection, said Dr. Myskowski, who advised bacterial and fungal cultures when infection is suspected.

Biological therapies, particularly epidermal growth factor receptor (EGFR) inhibitors and tyrosine kinase inhibitors (TKIs), also are associated with a high rate of nail disorders, including paronychia, pyogenic granuloma, and infection. Although nail disorders are far less common than the characteristic rash associated with these agents, she cited one study suggesting a 12% incidence of symptomatic paronychia on EGFR inhibitors. Typically, nail complications emerge about 2 months after treatment is initiated.

To prevent paronychia associated with EGFR inhibitors, Dr. Myskowksi recommended following guidelines issued by the National Comprehensive Cancer Network (J. Natl. Compr. Canc. Netw. 2009;75:S5-S21).

Recommendations include avoiding frequent water immersion as well as contact with harsh chemicals. Applying petroleum jelly to the periungual soft tissue may be protective. In the event of nail infection, augmenting antibiotic therapy with topical therapies such as silver nitrate solution or white vinegar soaks may speed healing. In patients who have reinfections of toenails, disposing of shoes that may harbor bacteria sometimes resolves the problem.

Dr. Myskowski reported no financial disclosures relevant to her presentation.

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PCR reveals multiple pathogens in onychomyosis

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NEW YORK – Diagnosis of fungal nail infection with polymerase chain reaction is demonstrating that the rates of mixed infection, including coinfection with dermatophyte and nondermatophyte molds, are substantially higher than that produced by cultures, according to a series of studies with implications for treatment selection.

The data may explain why some infections persist despite therapy and could lead to more frequent use of PCR as a diagnostic tool, Dr. Aditya K. Gupta reported at the American Academy of Dermatology summer meeting.

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Rates of mixed fungal nail infection, including coinfection with dermatophyte and nondermatophyte molds, are substantially higher than that produced by cultures, said Dr. Aditya Gupta.

PCR is far more sensitive than culture for identification of dermatophytes and nondermatophytes, and, unlike culture, PCR can detect the presence of multiple fungi in the same sample, according to Dr. Gupta, a dermatologist at Sunnybrook and Women’s College Health Sciences Center, Toronto.

Based on studies at his institution, he reported that two or more pathogens are more common than previously appreciated "and this is really important," because it has immediate implications for selecting broader spectrum agents to increase the likelihood of mycologic cure.

"A lot of treatment failures that we attribute to lack of efficacy of the agent may in fact be a reflection of the fact that there is a nondermatophyte mold that is present, evading therapy," Dr. Gupta said.

In a series of 155 patients, PCR was positive for dermatophytes in 44% of patients when culture was positive in 20%. Positive findings were 14% and 7% for PCR and culture, respectively, for nondermatophytes.

PCR is now being used routinely at Dr. Gupta’s institution not only because of its ability to detect mixed infections but also because it is about twice as sensitive as culture for detecting nail fungi.

Dr. Gupta predicted wider use of PCR in onychomycosis because of its greater sensitivity, noting however, that cost may be an obstacle. The potential difficulty of obtaining third-party reimbursement for PCR, which is substantially more expensive than a culture is, was raised in the discussion period by several dermatologists who were impressed with these results. At Dr. Gupta’s center, cost has not been an issue because PCR is being performed as part of a research initiative, but the greater diagnostic accuracy may be relevant to a cost-benefit analysis that includes an opportunity to increase the proportion of patients initiated on an optimal therapy for the underlying pathogen, Dr. Gupta said.

Dr. Gupta reported that he has financial relationships with Valeant, NuvoLase, Bristol-Myers Squibb, Novartis, and Janssen. The study was not commercially sponsored.

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NEW YORK – Diagnosis of fungal nail infection with polymerase chain reaction is demonstrating that the rates of mixed infection, including coinfection with dermatophyte and nondermatophyte molds, are substantially higher than that produced by cultures, according to a series of studies with implications for treatment selection.

The data may explain why some infections persist despite therapy and could lead to more frequent use of PCR as a diagnostic tool, Dr. Aditya K. Gupta reported at the American Academy of Dermatology summer meeting.

©istockphoto/thinkstockphotos.com
Rates of mixed fungal nail infection, including coinfection with dermatophyte and nondermatophyte molds, are substantially higher than that produced by cultures, said Dr. Aditya Gupta.

PCR is far more sensitive than culture for identification of dermatophytes and nondermatophytes, and, unlike culture, PCR can detect the presence of multiple fungi in the same sample, according to Dr. Gupta, a dermatologist at Sunnybrook and Women’s College Health Sciences Center, Toronto.

Based on studies at his institution, he reported that two or more pathogens are more common than previously appreciated "and this is really important," because it has immediate implications for selecting broader spectrum agents to increase the likelihood of mycologic cure.

"A lot of treatment failures that we attribute to lack of efficacy of the agent may in fact be a reflection of the fact that there is a nondermatophyte mold that is present, evading therapy," Dr. Gupta said.

In a series of 155 patients, PCR was positive for dermatophytes in 44% of patients when culture was positive in 20%. Positive findings were 14% and 7% for PCR and culture, respectively, for nondermatophytes.

PCR is now being used routinely at Dr. Gupta’s institution not only because of its ability to detect mixed infections but also because it is about twice as sensitive as culture for detecting nail fungi.

Dr. Gupta predicted wider use of PCR in onychomycosis because of its greater sensitivity, noting however, that cost may be an obstacle. The potential difficulty of obtaining third-party reimbursement for PCR, which is substantially more expensive than a culture is, was raised in the discussion period by several dermatologists who were impressed with these results. At Dr. Gupta’s center, cost has not been an issue because PCR is being performed as part of a research initiative, but the greater diagnostic accuracy may be relevant to a cost-benefit analysis that includes an opportunity to increase the proportion of patients initiated on an optimal therapy for the underlying pathogen, Dr. Gupta said.

Dr. Gupta reported that he has financial relationships with Valeant, NuvoLase, Bristol-Myers Squibb, Novartis, and Janssen. The study was not commercially sponsored.

NEW YORK – Diagnosis of fungal nail infection with polymerase chain reaction is demonstrating that the rates of mixed infection, including coinfection with dermatophyte and nondermatophyte molds, are substantially higher than that produced by cultures, according to a series of studies with implications for treatment selection.

The data may explain why some infections persist despite therapy and could lead to more frequent use of PCR as a diagnostic tool, Dr. Aditya K. Gupta reported at the American Academy of Dermatology summer meeting.

©istockphoto/thinkstockphotos.com
Rates of mixed fungal nail infection, including coinfection with dermatophyte and nondermatophyte molds, are substantially higher than that produced by cultures, said Dr. Aditya Gupta.

PCR is far more sensitive than culture for identification of dermatophytes and nondermatophytes, and, unlike culture, PCR can detect the presence of multiple fungi in the same sample, according to Dr. Gupta, a dermatologist at Sunnybrook and Women’s College Health Sciences Center, Toronto.

Based on studies at his institution, he reported that two or more pathogens are more common than previously appreciated "and this is really important," because it has immediate implications for selecting broader spectrum agents to increase the likelihood of mycologic cure.

"A lot of treatment failures that we attribute to lack of efficacy of the agent may in fact be a reflection of the fact that there is a nondermatophyte mold that is present, evading therapy," Dr. Gupta said.

In a series of 155 patients, PCR was positive for dermatophytes in 44% of patients when culture was positive in 20%. Positive findings were 14% and 7% for PCR and culture, respectively, for nondermatophytes.

PCR is now being used routinely at Dr. Gupta’s institution not only because of its ability to detect mixed infections but also because it is about twice as sensitive as culture for detecting nail fungi.

Dr. Gupta predicted wider use of PCR in onychomycosis because of its greater sensitivity, noting however, that cost may be an obstacle. The potential difficulty of obtaining third-party reimbursement for PCR, which is substantially more expensive than a culture is, was raised in the discussion period by several dermatologists who were impressed with these results. At Dr. Gupta’s center, cost has not been an issue because PCR is being performed as part of a research initiative, but the greater diagnostic accuracy may be relevant to a cost-benefit analysis that includes an opportunity to increase the proportion of patients initiated on an optimal therapy for the underlying pathogen, Dr. Gupta said.

Dr. Gupta reported that he has financial relationships with Valeant, NuvoLase, Bristol-Myers Squibb, Novartis, and Janssen. The study was not commercially sponsored.

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AT THE AAD SUMMER ACADEMY 2013

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Major finding: PCR is twice as effective as culture for the identification of pathogens causing onychomycosis.

Data source: Single-center study comparing diagnostic techniques in patient series

Disclosures: Dr. Gupta reported that he has financial relationships with Valeant, NuvoLase, Bristol-Myers Squibb, Novartis, and Janssen. The study was not commercially sponsored.

Fungal Diseases: How We Recognize and Treat Them

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Fungal Diseases: How We Recognize and Treat Them

Watch Dr. Phoebe Rich present an insightful overview of several fungal diseases and available topical and oral medications. This webcast is sponsored by Merz Pharmaceuticals, LLC.

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Watch Dr. Phoebe Rich present an insightful overview of several fungal diseases and available topical and oral medications. This webcast is sponsored by Merz Pharmaceuticals, LLC.

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Watch Dr. Phoebe Rich present an insightful overview of several fungal diseases and available topical and oral medications. This webcast is sponsored by Merz Pharmaceuticals, LLC.

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FDA issues strong warning about oral ketoconazole

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FDA issues strong warning about oral ketoconazole

Ketoconazole tablets should not be used as a first-line treatment for fungal infections because treatment has been associated with an increased risk of adrenal insufficiency, potentially fatal hepatotoxicity, and drug interactions, the Food and Drug Administration has announced.

Marketed as Nizoral, oral ketoconazole is no longer indicated for the treatment of Candida and dermatophyte infections and "should be used only for the treatment of certain life-threatening mycoses when the potential benefits outweigh the risks and alternative therapeutic options are not available or tolerated," according to the MedWatch safety alert issued on July 26.

In addition, oral ketoconazole should not be used to treat fungal infections of the skin and nails, and is only indicated for the treatment of blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis "in patients in whom other treatments have failed or who are intolerant to other therapies," according to the label, which has been modified to reflect these risks and recommendations.

There is now a Medication Guide that will be provided to patients with each filled prescription of oral ketoconazole, explaining the risks.

Because oral ketoconazole has been associated with hepatoxicity that can result in liver transplantation or death, it is now contraindicated in patients with acute or chronic liver disease. The label also now recommends that patients be assessed and monitored for liver toxicity. Monitoring of adrenal function also is now recommended in patients who take the oral formulation of the drug and have adrenal problems or "are under prolonged periods of stress such as those who have had a recent major surgery or who are under intensive care in the hospital."

In addition, coadministration of ketoconazole – a potent inhibitor of the cytochrome P450 3A4 isoenzyme (CYP3A4) – with certain drugs is either restricted or contraindicated because of the increase in drug concentrations and increased risk of QT prolongation and other serious reactions. Contraindicated drugs include dofetilide, quinidine, pimozide, and cisapride.

The FDA changes are based on risk-benefit analyses of data that include reports made to the FDA’s Adverse Events Reporting System.

On July 26, the European Medicines Agency’s Committee on Medicinal Products for Human Use (CHMP) announced that it has concluded that the risk of hepatoxicity with oral ketoconazole products was greater than the benefits in treating fungal infections and recommended that these products no longer be marketed in the European Union.

Creams, shampoos, and other topical ketoconazole formulations have not been associated with these problems, according to the FDA.

The updated label is available here. Serious adverse events associated with ketoconazole should be reported to the FDA at 800-332-1088 or MedWatch.

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Ketoconazole tablets should not be used as a first-line treatment for fungal infections because treatment has been associated with an increased risk of adrenal insufficiency, potentially fatal hepatotoxicity, and drug interactions, the Food and Drug Administration has announced.

Marketed as Nizoral, oral ketoconazole is no longer indicated for the treatment of Candida and dermatophyte infections and "should be used only for the treatment of certain life-threatening mycoses when the potential benefits outweigh the risks and alternative therapeutic options are not available or tolerated," according to the MedWatch safety alert issued on July 26.

In addition, oral ketoconazole should not be used to treat fungal infections of the skin and nails, and is only indicated for the treatment of blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis "in patients in whom other treatments have failed or who are intolerant to other therapies," according to the label, which has been modified to reflect these risks and recommendations.

There is now a Medication Guide that will be provided to patients with each filled prescription of oral ketoconazole, explaining the risks.

Because oral ketoconazole has been associated with hepatoxicity that can result in liver transplantation or death, it is now contraindicated in patients with acute or chronic liver disease. The label also now recommends that patients be assessed and monitored for liver toxicity. Monitoring of adrenal function also is now recommended in patients who take the oral formulation of the drug and have adrenal problems or "are under prolonged periods of stress such as those who have had a recent major surgery or who are under intensive care in the hospital."

In addition, coadministration of ketoconazole – a potent inhibitor of the cytochrome P450 3A4 isoenzyme (CYP3A4) – with certain drugs is either restricted or contraindicated because of the increase in drug concentrations and increased risk of QT prolongation and other serious reactions. Contraindicated drugs include dofetilide, quinidine, pimozide, and cisapride.

The FDA changes are based on risk-benefit analyses of data that include reports made to the FDA’s Adverse Events Reporting System.

On July 26, the European Medicines Agency’s Committee on Medicinal Products for Human Use (CHMP) announced that it has concluded that the risk of hepatoxicity with oral ketoconazole products was greater than the benefits in treating fungal infections and recommended that these products no longer be marketed in the European Union.

Creams, shampoos, and other topical ketoconazole formulations have not been associated with these problems, according to the FDA.

The updated label is available here. Serious adverse events associated with ketoconazole should be reported to the FDA at 800-332-1088 or MedWatch.

[email protected]

Ketoconazole tablets should not be used as a first-line treatment for fungal infections because treatment has been associated with an increased risk of adrenal insufficiency, potentially fatal hepatotoxicity, and drug interactions, the Food and Drug Administration has announced.

Marketed as Nizoral, oral ketoconazole is no longer indicated for the treatment of Candida and dermatophyte infections and "should be used only for the treatment of certain life-threatening mycoses when the potential benefits outweigh the risks and alternative therapeutic options are not available or tolerated," according to the MedWatch safety alert issued on July 26.

In addition, oral ketoconazole should not be used to treat fungal infections of the skin and nails, and is only indicated for the treatment of blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis "in patients in whom other treatments have failed or who are intolerant to other therapies," according to the label, which has been modified to reflect these risks and recommendations.

There is now a Medication Guide that will be provided to patients with each filled prescription of oral ketoconazole, explaining the risks.

Because oral ketoconazole has been associated with hepatoxicity that can result in liver transplantation or death, it is now contraindicated in patients with acute or chronic liver disease. The label also now recommends that patients be assessed and monitored for liver toxicity. Monitoring of adrenal function also is now recommended in patients who take the oral formulation of the drug and have adrenal problems or "are under prolonged periods of stress such as those who have had a recent major surgery or who are under intensive care in the hospital."

In addition, coadministration of ketoconazole – a potent inhibitor of the cytochrome P450 3A4 isoenzyme (CYP3A4) – with certain drugs is either restricted or contraindicated because of the increase in drug concentrations and increased risk of QT prolongation and other serious reactions. Contraindicated drugs include dofetilide, quinidine, pimozide, and cisapride.

The FDA changes are based on risk-benefit analyses of data that include reports made to the FDA’s Adverse Events Reporting System.

On July 26, the European Medicines Agency’s Committee on Medicinal Products for Human Use (CHMP) announced that it has concluded that the risk of hepatoxicity with oral ketoconazole products was greater than the benefits in treating fungal infections and recommended that these products no longer be marketed in the European Union.

Creams, shampoos, and other topical ketoconazole formulations have not been associated with these problems, according to the FDA.

The updated label is available here. Serious adverse events associated with ketoconazole should be reported to the FDA at 800-332-1088 or MedWatch.

[email protected]

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Make your scalp surgery seamless

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WASHINGTON – To make scalp surgery seamless, remember what makes the scalp unique: hair and tension, Dr. Mark Welch said.

The scalp is "a bloodless plain," said Dr. Welch of the Skin Cancer Surgery Center in Bethesda, Md.

Also, the scalp is painless, so it’s possible to go beyond the field of anesthesia, he noted at the Atlantic Dermatological Conference.

To keep hair out of the surgical field, Dr. Welch uses a razor to shave the immediate area, and then tapes down the surrounding hair. "The surrounding hair will find its way into your surgery site and wound," he said. Alternatively, moistening the hair with saline or water can keep it away from the surgical field. Tubular bandaging also can be used to hold the hair away from the surgery site.

The tension on the scalp presents a unique surgical challenge, said Dr. Welch. "The scalp skin is holding the weight of the body; there’s lots of tension up there."

Dr. Welch said he starts with a temporary pulley stitch to decrease the distance across the wound, which allows easier placement of subcutaneous stitches. "Then the pulley stitch can come out," he said.

"One technique I use a lot is preplaced subcutaneous sutures," Dr. Welch said. "You leave yourself a tail long enough to tie, then go posterior to the first subcutaneous stitch, and then go back and tie the first stitch, then the second, then go to the external stitches."

Dr. Welch said he uses a running stitch for external stitches. "On the last external running stitch, go out and come back in on the same side, and angle it back slightly." This technique allows for a more perpendicular closing to the wound edge, he explained.

Dr. Welch cited one case of a large defect in a patient with skin cancer on the scalp. He opted for a pulley stitch with gel foam in the center, and some silver nitrate. The wound was essentially healed in 8 weeks, even without the defect being completely closed.

For scalp dressings, Dr. Welch said he often prefers a Xeroform gauze bolster, which he sews in place, "so we don’t have to use any tape." When the stitches come out after a week, flexible collodion can be used. "It hardens, and over the next 3 or 4 weeks of shampooing, it flakes off."

When using wraps, Dr. Welch recommends combining vertical and horizontal wraps to create tension and promote healing.

He said he had no financial conflicts to disclose.

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WASHINGTON – To make scalp surgery seamless, remember what makes the scalp unique: hair and tension, Dr. Mark Welch said.

The scalp is "a bloodless plain," said Dr. Welch of the Skin Cancer Surgery Center in Bethesda, Md.

Also, the scalp is painless, so it’s possible to go beyond the field of anesthesia, he noted at the Atlantic Dermatological Conference.

To keep hair out of the surgical field, Dr. Welch uses a razor to shave the immediate area, and then tapes down the surrounding hair. "The surrounding hair will find its way into your surgery site and wound," he said. Alternatively, moistening the hair with saline or water can keep it away from the surgical field. Tubular bandaging also can be used to hold the hair away from the surgery site.

The tension on the scalp presents a unique surgical challenge, said Dr. Welch. "The scalp skin is holding the weight of the body; there’s lots of tension up there."

Dr. Welch said he starts with a temporary pulley stitch to decrease the distance across the wound, which allows easier placement of subcutaneous stitches. "Then the pulley stitch can come out," he said.

"One technique I use a lot is preplaced subcutaneous sutures," Dr. Welch said. "You leave yourself a tail long enough to tie, then go posterior to the first subcutaneous stitch, and then go back and tie the first stitch, then the second, then go to the external stitches."

Dr. Welch said he uses a running stitch for external stitches. "On the last external running stitch, go out and come back in on the same side, and angle it back slightly." This technique allows for a more perpendicular closing to the wound edge, he explained.

Dr. Welch cited one case of a large defect in a patient with skin cancer on the scalp. He opted for a pulley stitch with gel foam in the center, and some silver nitrate. The wound was essentially healed in 8 weeks, even without the defect being completely closed.

For scalp dressings, Dr. Welch said he often prefers a Xeroform gauze bolster, which he sews in place, "so we don’t have to use any tape." When the stitches come out after a week, flexible collodion can be used. "It hardens, and over the next 3 or 4 weeks of shampooing, it flakes off."

When using wraps, Dr. Welch recommends combining vertical and horizontal wraps to create tension and promote healing.

He said he had no financial conflicts to disclose.

[email protected]

WASHINGTON – To make scalp surgery seamless, remember what makes the scalp unique: hair and tension, Dr. Mark Welch said.

The scalp is "a bloodless plain," said Dr. Welch of the Skin Cancer Surgery Center in Bethesda, Md.

Also, the scalp is painless, so it’s possible to go beyond the field of anesthesia, he noted at the Atlantic Dermatological Conference.

To keep hair out of the surgical field, Dr. Welch uses a razor to shave the immediate area, and then tapes down the surrounding hair. "The surrounding hair will find its way into your surgery site and wound," he said. Alternatively, moistening the hair with saline or water can keep it away from the surgical field. Tubular bandaging also can be used to hold the hair away from the surgery site.

The tension on the scalp presents a unique surgical challenge, said Dr. Welch. "The scalp skin is holding the weight of the body; there’s lots of tension up there."

Dr. Welch said he starts with a temporary pulley stitch to decrease the distance across the wound, which allows easier placement of subcutaneous stitches. "Then the pulley stitch can come out," he said.

"One technique I use a lot is preplaced subcutaneous sutures," Dr. Welch said. "You leave yourself a tail long enough to tie, then go posterior to the first subcutaneous stitch, and then go back and tie the first stitch, then the second, then go to the external stitches."

Dr. Welch said he uses a running stitch for external stitches. "On the last external running stitch, go out and come back in on the same side, and angle it back slightly." This technique allows for a more perpendicular closing to the wound edge, he explained.

Dr. Welch cited one case of a large defect in a patient with skin cancer on the scalp. He opted for a pulley stitch with gel foam in the center, and some silver nitrate. The wound was essentially healed in 8 weeks, even without the defect being completely closed.

For scalp dressings, Dr. Welch said he often prefers a Xeroform gauze bolster, which he sews in place, "so we don’t have to use any tape." When the stitches come out after a week, flexible collodion can be used. "It hardens, and over the next 3 or 4 weeks of shampooing, it flakes off."

When using wraps, Dr. Welch recommends combining vertical and horizontal wraps to create tension and promote healing.

He said he had no financial conflicts to disclose.

[email protected]

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Nail surgery made simple

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WASHINGTON – There’s a lot of anxiety about nail surgery, particularly nail biopsies, for both physicians and patients, according to Dr. Maral K. Skelsey.

The goals of successful nail surgery are threefold: avoid complications, reduce patient pain and anxiety, and optimize pathologic diagnosis, said Dr. Skelsey of Georgetown University Medical Center in Washington.

Because nail surgery is often performed to obtain a clinical diagnosis, a good specimen is needed to allow the dermatopathologist to make a diagnosis, she noted at the Atlantic Dermatological Conference.

Approach preoperative assessment for nail surgery as any other surgery, said Dr. Skelsey. Take a full history, including information about vascular impairment, arterial disease, latex allergies, and a history of anticoagulant use. "We don’t stop anticoagulants, usually," Dr. Skelsey noted, but she does assess the prothrombin time (PT/INR) within 1 week.

Also, don’t underestimate the value of an x-ray. "One thing I have found physicians don’t do often" is to x-ray to check for bony changes and any anatomic abnormalities, she said.

To help optimize nail surgery outcomes, Dr. Skelsey recommended the following preoperative instructions for patients: Remove nail polish, scrub the area with povidone-iodine twice daily for 3 days prior to surgery, bring open-toed shoes (for toenail surgeries), arrange for a ride home, and plan to elevate the hand or foot as much as possible for the first 48 hours following the procedure.

Also, it "will help reduce morbidity if you tell your patients ahead of time to reduce their exercise and activity" immediately after the procedure, she said.

The right tools "will make your nail surgery much more successful," Dr. Skelsey said. Her essential tools: a nail splitter, nail nipper, and nail elevator.

Allow the patient to recline with goggles and ear phones to reduce anxiety during the procedure, she said.

For anesthesia, "I always use a 30-gauge needle, injecting very slowly," she said. She prefers a wing block, injecting slowly at a 45-degree angle towards the bone. This injection also acts as a volumetric tourniquet.

When obtaining the specimen during nail surgery, "visualize the location of the pathology by reflecting the proximal nail fold with a suture of skin hook and full or partial nail avulsion," said Dr. Skelsey.

"You can use a punch biopsy for longitudinal melanonychia less than 3 mm," she noted, but for anything more than 3 mm, a transverse excision or shave biopsy with a tangential excision is needed.

After the biopsy, Dr. Skelsey said that she applies an absorbable gelatin sponge saturated in aluminum chloride.

"What’s very important is giving your dermatopathologist a good specimen," she said. Don’t forget to ink the margins and orient the specimen. "You don’t want to go through all this trouble and have someone tell you there is nothing there," she added. She also recommended using separate, labelled formalin jars for the nail plate, bed, and matrix.

Dr. Skelsey said that she had no financial conflicts to disclose.

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WASHINGTON – There’s a lot of anxiety about nail surgery, particularly nail biopsies, for both physicians and patients, according to Dr. Maral K. Skelsey.

The goals of successful nail surgery are threefold: avoid complications, reduce patient pain and anxiety, and optimize pathologic diagnosis, said Dr. Skelsey of Georgetown University Medical Center in Washington.

Because nail surgery is often performed to obtain a clinical diagnosis, a good specimen is needed to allow the dermatopathologist to make a diagnosis, she noted at the Atlantic Dermatological Conference.

Approach preoperative assessment for nail surgery as any other surgery, said Dr. Skelsey. Take a full history, including information about vascular impairment, arterial disease, latex allergies, and a history of anticoagulant use. "We don’t stop anticoagulants, usually," Dr. Skelsey noted, but she does assess the prothrombin time (PT/INR) within 1 week.

Also, don’t underestimate the value of an x-ray. "One thing I have found physicians don’t do often" is to x-ray to check for bony changes and any anatomic abnormalities, she said.

To help optimize nail surgery outcomes, Dr. Skelsey recommended the following preoperative instructions for patients: Remove nail polish, scrub the area with povidone-iodine twice daily for 3 days prior to surgery, bring open-toed shoes (for toenail surgeries), arrange for a ride home, and plan to elevate the hand or foot as much as possible for the first 48 hours following the procedure.

Also, it "will help reduce morbidity if you tell your patients ahead of time to reduce their exercise and activity" immediately after the procedure, she said.

The right tools "will make your nail surgery much more successful," Dr. Skelsey said. Her essential tools: a nail splitter, nail nipper, and nail elevator.

Allow the patient to recline with goggles and ear phones to reduce anxiety during the procedure, she said.

For anesthesia, "I always use a 30-gauge needle, injecting very slowly," she said. She prefers a wing block, injecting slowly at a 45-degree angle towards the bone. This injection also acts as a volumetric tourniquet.

When obtaining the specimen during nail surgery, "visualize the location of the pathology by reflecting the proximal nail fold with a suture of skin hook and full or partial nail avulsion," said Dr. Skelsey.

"You can use a punch biopsy for longitudinal melanonychia less than 3 mm," she noted, but for anything more than 3 mm, a transverse excision or shave biopsy with a tangential excision is needed.

After the biopsy, Dr. Skelsey said that she applies an absorbable gelatin sponge saturated in aluminum chloride.

"What’s very important is giving your dermatopathologist a good specimen," she said. Don’t forget to ink the margins and orient the specimen. "You don’t want to go through all this trouble and have someone tell you there is nothing there," she added. She also recommended using separate, labelled formalin jars for the nail plate, bed, and matrix.

Dr. Skelsey said that she had no financial conflicts to disclose.

[email protected]

WASHINGTON – There’s a lot of anxiety about nail surgery, particularly nail biopsies, for both physicians and patients, according to Dr. Maral K. Skelsey.

The goals of successful nail surgery are threefold: avoid complications, reduce patient pain and anxiety, and optimize pathologic diagnosis, said Dr. Skelsey of Georgetown University Medical Center in Washington.

Because nail surgery is often performed to obtain a clinical diagnosis, a good specimen is needed to allow the dermatopathologist to make a diagnosis, she noted at the Atlantic Dermatological Conference.

Approach preoperative assessment for nail surgery as any other surgery, said Dr. Skelsey. Take a full history, including information about vascular impairment, arterial disease, latex allergies, and a history of anticoagulant use. "We don’t stop anticoagulants, usually," Dr. Skelsey noted, but she does assess the prothrombin time (PT/INR) within 1 week.

Also, don’t underestimate the value of an x-ray. "One thing I have found physicians don’t do often" is to x-ray to check for bony changes and any anatomic abnormalities, she said.

To help optimize nail surgery outcomes, Dr. Skelsey recommended the following preoperative instructions for patients: Remove nail polish, scrub the area with povidone-iodine twice daily for 3 days prior to surgery, bring open-toed shoes (for toenail surgeries), arrange for a ride home, and plan to elevate the hand or foot as much as possible for the first 48 hours following the procedure.

Also, it "will help reduce morbidity if you tell your patients ahead of time to reduce their exercise and activity" immediately after the procedure, she said.

The right tools "will make your nail surgery much more successful," Dr. Skelsey said. Her essential tools: a nail splitter, nail nipper, and nail elevator.

Allow the patient to recline with goggles and ear phones to reduce anxiety during the procedure, she said.

For anesthesia, "I always use a 30-gauge needle, injecting very slowly," she said. She prefers a wing block, injecting slowly at a 45-degree angle towards the bone. This injection also acts as a volumetric tourniquet.

When obtaining the specimen during nail surgery, "visualize the location of the pathology by reflecting the proximal nail fold with a suture of skin hook and full or partial nail avulsion," said Dr. Skelsey.

"You can use a punch biopsy for longitudinal melanonychia less than 3 mm," she noted, but for anything more than 3 mm, a transverse excision or shave biopsy with a tangential excision is needed.

After the biopsy, Dr. Skelsey said that she applies an absorbable gelatin sponge saturated in aluminum chloride.

"What’s very important is giving your dermatopathologist a good specimen," she said. Don’t forget to ink the margins and orient the specimen. "You don’t want to go through all this trouble and have someone tell you there is nothing there," she added. She also recommended using separate, labelled formalin jars for the nail plate, bed, and matrix.

Dr. Skelsey said that she had no financial conflicts to disclose.

[email protected]

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Lichen Planopilaris

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Topical Treatment of Onychomycosis With Efinaconazole Solution 10%

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Pili Annulati: A Report of 2 American Families

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