Complication, Pain, Postoperative, Quality of Life, Relapse
Conditions
Keywords
Ingrown nail, Simple surgery, Surgery with chemical cauterisation, Trichloroacetic acid, Relapse, Quality of life
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.
Interventions
PROCEDUREIngrown toenails with surgery with chemical cauterisation
Removal of the ingrown lateral part of the toenail and chemical cauterisation
PROCEDUREIngrown toenails with only surgery
Removal of the ingrown lateral part of the toenail with directed Healing pad
Sponsors
University Hospital, Caen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapses | one year | Relapses of ingrown toenail on the operated nail |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 ? |
| 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 |
Countries
France
Contacts
Primary ContactGASLAIN NICOLAS
Backup ContactPr DOMPMARTIN ANNE
Outcome results
None listed