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

• Sponsor: University Hospital, Caen (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04921540
• Collaborator: (none)
• Enrollment: 50
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site: 25
• Patients Per Site Per Month: 1

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Sep 1, 2020
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Relapses [one year]

   Relapses of ingrown toenail on the operated nail

Secondary Outcome Measures

1. 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 ?

2. Complications [At one week and one month after surgery]

   Bleeding, infection, pain

3. 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)

4. Time before restart sport [Restart sport at one month yes/no]

   Time to recover a normal physical activity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 80 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre hospitalier universitaire de CAEN	Caen	Normandie	France	14000
2	Centre hospitalier Mémorial France Etats Unis	Saint-Lô	Normandie	France	50000

Sponsors and Collaborators

• University Hospital, Caen

Investigators

• Study Director: Pr DOMPMARTIN ANNE, CHU CAEN

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Caen
• ClinicalTrials.gov Identifier: NCT04921540
• Other Study ID Numbers: 20-090
• First Posted: Jun 10, 2021
• Last Update Posted: Jun 10, 2021
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Recurrence; Pain, Postoperative

Study Results

No Results Posted as of Jun 10, 2021