Ingrown Toenails : Surgery Only Versus Surgery + Chemical Cauterization With TCA

Study Overview
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Brief Summary
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Ingrown toenail is a very common disease in the general population that touches young adults. There are lots of treatments from local care of pedicure to surgery with matricectomy. Gold standard of symptomatic and painful ingrown toenail is the simple surgery with matricectomy and with suture or directed healing pad. For many years chemical cauterisation with phenolic acid is used, a method with very few relapses and with a more simple pad. However, because of a lack of information about this phenolic acid, the pharmaceutical laboratory withdrew it from the market. The new method to replace phenolic acid is trichloroacetic acid, used mainly in cosmetics for peeling. This method was already compared to phenolic acid and showed equal results with fewer laps of application and a low cost. The comparison between acid trichloroacetic method and the gold standard surgery was never done and will be the goal of this study. It's an open, non randomised, comparative, multicentric (2 centers) study with two groups : common surgery and surgery with chemical cauterisation For this study the investigators will compare between the two groups : gain of quality of life at one month after surgery, difference of pain between before, one week and one month after surgery, the occurrence of adverse events and number of relapses at one year.

Official Title
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Etude Comparative Multicentrique Prospective évaluant la Prise en Charge Chirurgicale associée à Une cautérisation Chimique Par Acide TCA Par Rapport à la Prise en Charge Chirurgicale Standard Dans le Traitement de l'Ongle incarné

Conditions
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Quality of Life, Complication, Pain, Postoperative, Relapse

Intervention / Treatment
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* Procedure: Ingrown toenails with surgery with chemical cauterisation
* Procedure: Ingrown toenails with only surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of ingrown toenail Patient informed and with signed informed consent Exclusion Criteria: Medical history of ingrown toenail on the concerned nail Other nail disease Pregnancy Allergy to local anesthetic or to trichloroacetic acid

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dermatologic intervention<br>Surgery with chemical cauterisation TCA | Procedure: Ingrown toenails with surgery with chemical cauterisation<br>* Removal of the ingrown lateral part of the toenail and chemical cauterisation<br>|
| Active Comparator: Orthopedic intervention<br>Only surgery | Procedure: Ingrown toenails with only surgery<br>* Removal of the ingrown lateral part of the toenail with directed Healing pad<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapses | Relapses of ingrown toenail on the operated nail | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gain of quality of life | Quality of life will be measured with the Dermatology Life Quality Index adapted to the nail, there are 9 questions that will be filled by the patient. Each questions have 4 possibilities to 0 (no problem) to 3(hugely). So the score go to 0 to 27. Questions are, on last 7 days : Did your nail itch, burn or hurt you ? Did you feel embarrassed or complexed by your nail ? Did you have problem to go shopping, to do the housework ? Did you have problem to put on your shoes? Did your nail problem affect your hobbies and activity ? Did you have problem to do sport ? Did your nail embarrased you in your job or your studies ? Did your nail complicate your relationship's with your friends, parents or spouse? Did your nail deteriorate your sexual life ? | Baseline and one month after the surgery | 
| Complications | Bleeding, infection, pain | At one week and one month after surgery | 
| Pain on the nail | Pain report on a numeric scale of pain to 0 (no pain) to 10(worst pain possible) | Baseline, one week and one month after surgery | 
| Time before restart sport | Time to recover a normal physical activity | Restart sport at one month yes/no | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ingrown nail, Simple surgery, Surgery with chemical cauterisation, Trichloroacetic acid, Relapse, Quality of life