Conservative Treatment of Ingrown Toenail

Study Overview
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Brief Summary
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Ingrown toenail has become one of the most prevalent onychopathies and a frequent reason for consultation in podiatry clinics. In the initial stages of the pathology, conservative treatments are the first choice of therapy. The aim was therefore, to analyze and compare the efficacy of the technique of nail re-education with gauze bandage and nail remodelling for the conservative treatment of onychocryptosis in stage I and IIA, A prospective, longitudinal, randomised clinical trial-type analytical study is proposed. A sample of 20 subjects with stage I and IIA onychocryptosis will be selected. Of these, 10 cases were part of the gauze bandage nail re-education group and the remaining 10 cases were part of the nail remodelling group.

Official Title
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Conservative Treatment of Ingrown Toenail in Stages I or IIa

Conditions
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Ingrown Nail, Nails, Abnormal

Intervention / Treatment
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* Procedure: Follow up of the clinical stage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ingrown toenail in stage I or IIa (Mozena Classification) Exclusion Criteria: Patients not allowed for clinical follow-up of the evolution of the pathology. Patients presented with deforming pathologies Pattens had been surgically operated for ingrown toenail

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spiculotomy and application of a Gel Nail<br>A nail spicule removal technique will be performed of the edge or nail edges affected by ingrown toenail. After, a gel nail will be applied to remodeling the nail apparatus and avoid damage of the nail in the lateral fold. | Procedure: Follow up of the clinical stage<br>* Pain, Swelling, Infection, Patient satisfaction and recurrence of the disease will be measured<br>|
| Active Comparator: Spiculotomy and Nail Re-education with Gauze Bandage<br>A nail spicule removal technique will be performed and a cord of gauze bandage between the nail channel and the sheet will be applied. This technique consists in the removal of the portion of the nail sheet that causes ingrown toenail in order to release the soft parts. | Procedure: Follow up of the clinical stage<br>* Pain, Swelling, Infection, Patient satisfaction and recurrence of the disease will be measured<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of the disease | Recurrence is defined as a return of the previous symptoms, regrowth of the nail edge, or patient dissatisfaction with the clinical outcome. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reported pain | Visual analogue scale of pain (0-10) | Every clinic visit of the patient until 3 months | 
| Infection | Presence of infection symptoms as oozing or built up fluid around the affected area, bleeding, foul smell, overgrowth tissues around the edges of the toenail or abscess filled with puss. | Every clinic visit of the patient until 3 months | 
| Swelling | Presence of swelling symptoms as pain, redness and hardardening around the affected toenail. | Every clinic visit of the patient until 3 months | 
| Patient satisfaction | Patient satisfaction survey (0-10) | Every clinic visit of the patient until 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ingrown toenail, Conservative treatment, Recurrence, Podiatry, Nail remodelling