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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04921540
• Other study ID #: 20-090
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: July 2020
• Source: University Hospital, Caen
• Contact: GASLAIN NICOLAS
• Phone: 0231272510
• Email: gaslain-n[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Complication
• Pain, Postoperative
• Quality of Life
• Recurrence
• Relapse

Intervention

Procedure:
• Ingrown toenails with surgery with chemical cauterisation
Removal of the ingrown lateral part of the toenail and chemical cauterisation
• Ingrown toenails with only surgery
Removal of the ingrown lateral part of the toenail with directed Healing pad

Locations

Country	Name	City	State
France	Centre hospitalier universitaire de CAEN	Caen	Normandie
France	Centre hospitalier Mémorial France Etats Unis	Saint-Lô	Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapses	Relapses of ingrown toenail on the operated nail	one year
Secondary	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
Secondary	Complications	Bleeding, infection, pain	At one week and one month after surgery
Secondary	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
Secondary	Time before restart sport	Time to recover a normal physical activity	Restart sport at one month yes/no