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

Primary Purpose

Relapse, Quality of Life, Complication

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ingrown toenails with surgery with chemical cauterisation
Ingrown toenails with only surgery
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapse focused on measuring Ingrown nail, Simple surgery, Surgery with chemical cauterisation, Trichloroacetic acid, Relapse, Quality of life

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre hospitalier universitaire de CAENRecruiting
  • Centre hospitalier Mémorial France Etats UnisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dermatologic intervention

Orthopedic intervention

Arm Description

Surgery with chemical cauterisation TCA

Only surgery

Outcomes

Primary Outcome Measures

Relapses
Relapses of ingrown toenail on the operated nail

Secondary Outcome Measures

Gain of quality of life
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
Bleeding, infection, pain
Pain on the nail
Pain report on a numeric scale of pain to 0 (no pain) to 10(worst pain possible)
Time before restart sport
Time to recover a normal physical activity

Full Information

First Posted
May 27, 2021
Last Updated
June 9, 2021
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT04921540
Brief Title
Ingrown Toenails : Surgery Only Versus Surgery + Chemical Cauterization With TCA
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapse, Quality of Life, Complication, Pain, Postoperative
Keywords
Ingrown nail, Simple surgery, Surgery with chemical cauterisation, Trichloroacetic acid, Relapse, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dermatologic intervention
Arm Type
Experimental
Arm Description
Surgery with chemical cauterisation TCA
Arm Title
Orthopedic intervention
Arm Type
Active Comparator
Arm Description
Only surgery
Intervention Type
Procedure
Intervention Name(s)
Ingrown toenails with surgery with chemical cauterisation
Intervention Description
Removal of the ingrown lateral part of the toenail and chemical cauterisation
Intervention Type
Procedure
Intervention Name(s)
Ingrown toenails with only surgery
Intervention Description
Removal of the ingrown lateral part of the toenail with directed Healing pad
Primary Outcome Measure Information:
Title
Relapses
Description
Relapses of ingrown toenail on the operated nail
Time Frame
one year
Secondary Outcome Measure Information:
Title
Gain of quality of life
Description
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 ?
Time Frame
Baseline and one month after the surgery
Title
Complications
Description
Bleeding, infection, pain
Time Frame
At one week and one month after surgery
Title
Pain on the nail
Description
Pain report on a numeric scale of pain to 0 (no pain) to 10(worst pain possible)
Time Frame
Baseline, one week and one month after surgery
Title
Time before restart sport
Description
Time to recover a normal physical activity
Time Frame
Restart sport at one month yes/no

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
GASLAIN NICOLAS
Phone
0231272510
Email
gaslain-n@chu-caen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Pr DOMPMARTIN ANNE
Email
dompmartin-a@chu-caen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pr DOMPMARTIN ANNE
Organizational Affiliation
CHU CAEN
Official's Role
Study Director
Facility Information:
Facility Name
Centre hospitalier universitaire de CAEN
City
Caen
State/Province
Normandie
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Secretariat DRCI
Phone
0231065781
Email
drci-secretariat@chu-caen.fr
Facility Name
Centre hospitalier Mémorial France Etats Unis
City
Saint-Lô
State/Province
Normandie
ZIP/Postal Code
50000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Unité de recherche clinique
Phone
0233067446
Email
gaelle.lambert@ch-stlo.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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