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

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ClinicalTrials.gov Identifier: NCT04921540
Recruitment Status : Recruiting
First Posted : June 10, 2021
Last Update Posted : June 10, 2021
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Relapse Quality of Life Complication Pain, Postoperative Procedure: Ingrown toenails with surgery with chemical cauterisation Procedure: Ingrown toenails with only surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2022

Arm Intervention/treatment
Experimental: Dermatologic intervention
Surgery with chemical cauterisation TCA
Procedure: Ingrown toenails with surgery with chemical cauterisation
Removal of the ingrown lateral part of the toenail and chemical cauterisation

Active Comparator: Orthopedic intervention
Only surgery
Procedure: Ingrown toenails with only surgery
Removal of the ingrown lateral part of the toenail with directed Healing pad




Primary Outcome Measures :
  1. Relapses [ Time Frame: one year ]
    Relapses of ingrown toenail on the operated nail


Secondary Outcome Measures :
  1. Gain of quality of life [ Time Frame: 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 ?

  2. Complications [ Time Frame: At one week and one month after surgery ]
    Bleeding, infection, pain

  3. Pain on the nail [ Time Frame: 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)

  4. Time before restart sport [ Time Frame: Restart sport at one month yes/no ]
    Time to recover a normal physical activity



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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04921540


Contacts
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Contact: GASLAIN NICOLAS 0231272510 gaslain-n@chu-caen.fr
Contact: Pr DOMPMARTIN ANNE dompmartin-a@chu-caen.fr

Locations
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France
Centre hospitalier universitaire de CAEN Recruiting
Caen, Normandie, France, 14000
Contact: Secretariat DRCI    0231065781    drci-secretariat@chu-caen.fr   
Centre hospitalier Mémorial France Etats Unis Recruiting
Saint-Lô, Normandie, France, 50000
Contact: Unité de recherche clinique    0233067446    gaelle.lambert@ch-stlo.fr   
Sponsors and Collaborators
University Hospital, Caen
Investigators
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Study Director: Pr DOMPMARTIN ANNE CHU CAEN
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT04921540    
Other Study ID Numbers: 20-090
First Posted: June 10, 2021    Key Record Dates
Last Update Posted: June 10, 2021
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Caen:
Ingrown nail
Simple surgery
Surgery with chemical cauterisation
Trichloroacetic acid
Relapse
Quality of life
Additional relevant MeSH terms:
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Recurrence
Pain, Postoperative
Disease Attributes
Pathologic Processes
Postoperative Complications
Pain
Neurologic Manifestations