Clinical trial NCT04921540: Ingrown Toenails : Surgery Only Versus Surgery + Chemical Cauterization With TCA
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Relapse
Quality of Life
Complication
Pain, Postoperative
Keywords: Ingrown nail
Simple surgery
Surgery with chemical cauterisation
Trichloroacetic acid
Relapse
Quality of life
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Relapses
timeFrame: one year
Secondary outcomes:
measure: Gain of quality of life
timeFrame: Baseline and one month after the surgery
measure: Complications
timeFrame: At one week and one month after surgery
measure: Pain on the nail
timeFrame: Baseline, one week and one month after surgery
measure: Time before restart sport
timeFrame: Restart sport at one month yes/no
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre hospitalier universitaire de CAEN
state: Normandie
city: Saint-Lô
country: France
facility: Centre hospitalier Mémorial France Etats Unis
state: Normandie
Study officials:
affiliation: CHU CAEN
name: Pr DOMPMARTIN ANNE
role: STUDY_DIRECTOR
References: