Comparison of 80% Trichloroacetic acid, 88% phenol and radiofrequency for matricectomy in treatment of ingrown toenail a prospective observational study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Pain during surgery
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Adult patients suffering from ingrown toenail undergoing partial or complete nail avulsion with matricectomy.
排除标准
- •Patients less than 18 years of age and patients planned for conservative management.
结局指标
主要结局
Pain during surgery
时间窗: day 0, 1 and 3 months
oozing after 1 day surgery
时间窗: day 0, 1 and 3 months
recurrence at 3 months
时间窗: day 0, 1 and 3 months
次要结局
- pain before surgery(demographic data)
研究者
DR MANASA KAYARKATTE NARAYAN
Department of Dermatology, Venereology and Leprosy, Kasturba Medical College, Mangalore
