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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University Hospital, Caen
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Relapses
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Dermatologic intervention
Surgery with chemical cauterisation TCA
Intervention: Ingrown toenails with surgery with chemical cauterisation (Procedure)
Orthopedic intervention
Only surgery
Intervention: Ingrown toenails with only surgery (Procedure)
Outcomes
Primary Outcomes
Relapses
Time Frame: one year
Relapses of ingrown toenail on the operated nail
Secondary Outcomes
- Complications(At one week and one month after surgery)
- Pain on the nail(Baseline, one week and one month after surgery)
- Time before restart sport(Restart sport at one month yes/no)
- Gain of quality of life(Baseline and one month after the surgery)