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

Not Applicable

• Conditions: Relapse; Quality of Life; Pain, Postoperative; Complication
• Interventions: Procedure: Ingrown toenails with only surgery; Procedure: Ingrown toenails with surgery with chemical cauterisation

• Registration Number: NCT04921540
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study Start: 2020-09-01
• Study First Submitted: 2021-05-27
• Study First Submitted QC: 2021-06-09
• Last Update Submitted: 2021-06-09
• Study First Posted: 2021-06-10
• Last Update Posted: 2021-06-10
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Orthopedic intervention	Ingrown toenails with only surgery	Only surgery
Dermatologic intervention	Ingrown toenails with surgery with chemical cauterisation	Surgery with chemical cauterisation TCA

Primary Outcome Measures

Name	Time	Method
Relapses	one year	Relapses of ingrown toenail on the operated nail

Secondary Outcome Measures

Name	Time	Method
Complications	At one week and one month after surgery	Bleeding, infection, pain
Pain on the nail	Baseline, one week and one month after surgery	Pain report on a numeric scale of pain to 0 (no pain) to 10(worst pain possible)
Time before restart sport	Restart sport at one month yes/no	Time to recover a normal physical activity
Gain of quality of life	Baseline and one month after the surgery	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 ?

Trial Locations

Locations (2)

Centre hospitalier Mémorial France Etats Unis; 🇫🇷 Saint-Lô, Normandie, France

Centre hospitalier universitaire de CAEN; 🇫🇷 Caen, Normandie, France