Ingrown Nail Clinical Trial
Official title:
Clinical Efficacy of Nail Brace for Treatment of Ingrown Toenails
Background: Ingrown toenails are one of the most frequent nail disorders and can be treated
with conservative or surgical approaches. Although discovered a long time ago, the available
data are still very limited on the potential effectiveness of nail braces for ingrown
toenail treatment.
Objective: This study aimed to evaluate the efficacy of nail brace (combiped and podofix)
for treatment of ingrown toenails.
Method: Participants with ingrown toenail and >= 12 years old with total 40 ingrown toenails
were included. Investigators divide patients to 3 group: (1) combiped group: Participants
with non-infected or mild infected ingrown nail, combiped nail brace was applied
instantly.20 patients(2) combine combiped and podofix group: Participants with severe
paronychia with pyogenic granuloma, oral analgesics and antibiotics were prescribed first
and nail brace was applied 1 week later. Depends on disease condition, investigators applied
1-2 combiped nail brace. If the pyogenic granuloma is not resolved after 1 week,
investigators applied podofix first for 2-4 weeks and then combiped nail brace. After the
nail brace applied, participants must come back between 2-4 weeks depends on disease
condition.10 patients (3) podofix group: participants who are afraid of combiped
implantation, or with mild recurrence will be applied with podofix.
Participants come back every month for evaluation and photography. Physician global
assessment (0-6),Patient global assessment (VAS 0-10), Treatment satisfaction (VAS 0-10),
and questionnaire were evaluated 1 month, 3 months and 6 months after the device applied.
Participants need to be followed for recurrence at 3rd month and 6th month after removed the
nail brace.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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