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

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

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.

Study Overview

• Status: Unknown
• Conditions: Quality of Life; Pain, Postoperative; Complication; Relapse
• Intervention / Treatment: Procedure: Ingrown toenails with surgery with chemical cauterisation; Procedure: Ingrown toenails with only surgery

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Normandie
    • Caen, Normandie, France, 14000
      • Recruiting
      • Centre Hospitalier Universitaire de Caen
      • Contact: Secretariat DRCI; Phone Number: 0231065781; Email: drci-secretariat@chu-caen.fr
    • Saint-Lô, Normandie, France, 50000
      • Recruiting
      • Centre hospitalier Mémorial France Etats Unis
      • Contact: Unité de recherche clinique; Phone Number: 0233067446; Email: gaelle.lambert@ch-stlo.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Study Director: Pr DOMPMARTIN ANNE, CHU Caen

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 10, 2021

Study Record Updates

• Last Update Posted (Actual): June 10, 2021
• Last Update Submitted That Met QC Criteria: June 9, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Quality of life; Relapse; Trichloroacetic acid; Ingrown nail; Simple surgery; Surgery with chemical cauterisation
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Disease Attributes; Pain, Postoperative; Recurrence
• Other Study ID Numbers: 20-090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No