Introduction:
Onychocryptosis
or ingrown toenail is a common condition of the nail unit causing pain,
discharge and infection. This causes significant impairment in quality of life.
Hence treatment for this is essential.
The
standard treatment now consists of nail avulsion with matricectomy. Matrix
destruction can be done with cauterization with chemicals or physical
destruction. Chemicals used can be trichloroacetic acid, phenol 88% or sodium
hydroxide. Physical destructive modalities include surgery and more recently
with radiofrequency, cryotherapy or ablative LASER.
Knowledge
gap identified
There
is a lack of study assessing the outcome comparing trichloroacetic acid 80%,
phenol 88% and radiofrequency ablation of the matrix in onychocryptosis.Aim: To compare the outcome
of 80% TCA, 88% phenol and radiofrequency for matricectomy in treatment of
ingrown toe nail
Aim: To compare the outcome
of 80% TCA, 88% phenol and radiofrequency for matricectomy in treatment of
ingrown toe nail
Objectives:
1. To
study demographic and clinical features of ingrown toenail
2. To
assess the pain at baseline, pain and or side effects if any during procedure
and post procedure following matricectomy in treatment of ingrown toenail
3. To
assess the recurrence rate amongst the three methods of matricectomy at 3months
Methodology:
a.
Study setting: Department of
Dermatology, Venereology and Leprosy, Kasturba Medical College, Mangalore, Government
Wenlock Hospital and KMC Attavar Hospital.
b.
Study design: Observational,
prospective, institutional based study.
c.
Study participants: Consenting
patients with ingrown toenail will be recruited from Government Wenlock
Hospital and KMC Attavar Hospital, who fulfil the inclusion criteria.
d.
Inclusion criteria: Adult patients
suffering from ingrown toenail undergoing partial or complete nail avulsion
with matricectomy.
e.
Exclusion criteria: Patients less
than 18 years of age and patients planned for conservative management
f.
Study duration: Jan 2025 to Dec 2027
(2 year)
g. Sample
size: 48 (16 patients in each group). Assuming there will be a minimum
difference of 0.5 in recurrence rate across three groups with 95% confidence
interval and 80% power, the sample size was calculated as 16 in each group. The
sample size was calculated using “Goodness of fit contingency tables” module in
G power version 3.1.9.4.
h.
Sampling method: Purposive sampling
i.
Tool for data collection: Pre-validated
proforma
j.
Data collection methodology: The
patients undergoing treatment for ingrowth toenail with matricectomy will be
recruited following informed consent. Pre-procedure photographs will be taken
and saved in an anonymous manner. Patient demographic data will be collected
and entered into the proforma. Pain will be assessed based on visual analogue
scale. The dermatologist who refers the patient for the surgery will decide the
type of matricectomy as per their clinical decision. The first 16 patients in
each group will be collected by the operating dermatologist and categorized to
group 1 (80% TCA), group 2 (88% Phenol) and group 3 (radiofrequency ablation)
and will note any intraoperative difficulties or side effects, this data will
be entered, and it will be coded and stored. Post procedure side-effect and
long-term outcome at follow up which is usually done at 3 months, will also be
noted. A photograph will be taken at this time and pre and post procedure photographs
will be compared by the dermatologist.
k.
Outcome variables:
Pain using visual analogue scale, rate of recurrence, ooze,
erythema, pain and swelling, or tissue damage. Drainage/ooze will be graded
as grade 0: no discharge, grade 1: minimal soakage of dressing with no visible discharge, grade 2: mild discharge on pressing
the folds only, grade 3: discharge visible on the toe, and grade 4: excessive
discharge. Recurrence if any will be graded with Mozena’s classification
[2].
Biological materials required:
None
Data analysis:
Data will be entered into Microsoft Excel. Analysis will be done using SPSS
version 29 (IBM Corp. Released 2023. IBM SPSS Statistics for Windows, Version
29.0.2.0 Armonk, NY: IBM Corp). Descriptive statistics for continuous variables
will be presented as mean with standard deviation (SD) or median with
interquartile range (IQR), while categorical variables will be summarized as
frequency and percentage. Associations between two categorical variables will
be tested using the chi-square test, and differences in pain across three
groups will be analyzed using analysis of variance (ANOVA). P-value less than
0.05 will be considered statistically significant.
Implications:
We will identify a safer and efficient method of matricectomy. |