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

C

Caen University Hospital

Status

Unknown

Conditions

Complication
Quality of Life
Relapse
Pain, Postoperative

Treatments

Procedure: Ingrown toenails with surgery with chemical cauterisation
Procedure: Ingrown toenails with only surgery

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

15 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Dermatologic intervention
Experimental group
Description:
Surgery with chemical cauterisation TCA
Treatment:
Procedure: Ingrown toenails with surgery with chemical cauterisation
Orthopedic intervention
Active Comparator group
Description:
Only surgery
Treatment:
Procedure: Ingrown toenails with only surgery

Trial contacts and locations

2

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Central trial contact

GASLAIN NICOLAS; Pr DOMPMARTIN ANNE

Data sourced from clinicaltrials.gov

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