NCT04921540

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 10, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

June 10, 2021

Status Verified

July 1, 2020

Enrollment Period

2 years

First QC Date

May 27, 2021

Last Update Submit

June 9, 2021

Conditions

RelapseQuality of LifeComplicationPain, Postoperative

Keywords

Ingrown nailSimple surgerySurgery with chemical cauterisationTrichloroacetic acidRelapseQuality of life

Outcome Measures

Primary Outcomes (1)

  • Relapses

    Relapses of ingrown toenail on the operated nail

    one year

Secondary Outcomes (4)

  • Gain of quality of life

    Baseline and one month after the surgery

  • 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

Study Arms (2)

Dermatologic intervention

EXPERIMENTAL

Surgery with chemical cauterisation TCA

Procedure: Ingrown toenails with surgery with chemical cauterisation

Orthopedic intervention

ACTIVE COMPARATOR

Only surgery

Procedure: Ingrown toenails with only surgery

Interventions

Ingrown toenails with surgery with chemical cauterisationPROCEDURE

Removal of the ingrown lateral part of the toenail and chemical cauterisation

Dermatologic intervention
Ingrown toenails with only surgeryPROCEDURE

Removal of the ingrown lateral part of the toenail with directed Healing pad

Orthopedic intervention

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of ingrown toenail
  • Patient informed and with signed informed consent

You may not qualify if:

  • Medical history of ingrown toenail on the concerned nail
  • Other nail disease
  • Pregnancy
  • Allergy to local anesthetic or to trichloroacetic acid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre hospitalier universitaire de CAEN

Caen, Normandy, 14000, France

RECRUITING

Centre hospitalier Mémorial France Etats Unis

Saint-Lô, Normandy, 50000, France

RECRUITING

MeSH Terms

Conditions

RecurrencePain, PostoperativeNails, Ingrown

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative ComplicationsPainNeurologic ManifestationsSigns and SymptomsNail DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Pr DOMPMARTIN ANNE

    CHU CAEN

    STUDY DIRECTOR

Central Study Contacts

GASLAIN NICOLAS

CONTACT

0231272510gaslain-n@chu-caen.fr

Pr DOMPMARTIN ANNE

CONTACT

dompmartin-a@chu-caen.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2021

First Posted

June 10, 2021

Study Start

September 1, 2020

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

June 10, 2021

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)