RelapseNCT04921540
Ingrown Toenails : Surgery Only Versus Surgery + Chemical Cauterization With TCA
A study testing Ingrown toenails with surgery with chemical cauterisation and Ingrown toenails with only surgery in people with Relapse and Quality of Life, run by University Hospital, Caen at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Relapse, Quality of Life, Complication
- What is being tested?
- Ingrown toenails with surgery with chemical cauterisation and Ingrown toenails with only surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Sep 2020to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of ingrown toenail
- Patient informed and with signed informed consent
Who cannot join
- Medical history of ingrown toenail on the concerned nail
- Other nail disease
- Pregnancy
- Allergy to local anesthetic or to trichloroacetic acid
Trial locations and contacts
2 sites in 1 country.
Pr DOMPMARTIN ANNE contact
France2 sites, 2 recruiting
- Recruiting
Centre hospitalier universitaire de CAEN
Caen, Normandy, 14000
Secretariat DRCI, 0231065781, drci-secretariat@chu-caen.fr
- Recruiting
Centre hospitalier Mémorial France Etats Unis
Saint-Lô, Normandy, 50000
Unité de recherche clinique, 0233067446, gaelle.lambert@ch-stlo.fr
About this study
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
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.
Read more
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.
- Conditions
- Relapse, Quality of Life, Complication, Pain, Postoperative
- Being tested
- Ingrown toenails with surgery with chemical cauterisation, Ingrown toenails with only surgery
- Keywords
- Ingrown nail, Simple surgery, Surgery with chemical cauterisation, Trichloroacetic acid, Relapse, Quality of life
- Medical subject headings
- Recurrence, Pain, Postoperative, Nails, Ingrown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ingrown toenails with surgery with chemical cauterisationProcedure or surgery
Removal of the ingrown lateral part of the toenail and chemical cauterisation
Ingrown toenails with only surgeryProcedure or surgery
Removal of the ingrown lateral part of the toenail with directed Healing pad
| Study group | Role | What they receive |
|---|---|---|
| Dermatologic intervention | Experimental | Surgery with chemical cauterisation TCA Receives: Procedure: Ingrown toenails with surgery with chemical cauterisation |
| Orthopedic intervention | Active comparator | Only surgery Receives: Procedure: Ingrown toenails with only surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapses
Relapses of ingrown toenail on the operated nail
Measured: one year
Secondary outcomes (4)
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 ?
Measured: Baseline and one month after the surgery
Complications
Bleeding, infection, pain
Measured: At one week and one month after surgery
Pain on the nail
Pain report on a numeric scale of pain to 0 (no pain) to 10(worst pain possible)
Measured: Baseline, one week and one month after surgery
Time before restart sport
Time to recover a normal physical activity
Measured: Restart sport at one month yes/no
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start1 Sep 2020
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RelapseStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pr DOMPMARTIN ANNE, Study director, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921540
- Sponsor's protocol ID
- 20-090
- Status last verified
- Jul 2020
- First submitted
- 27 May 2021
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04921540
- Acronym / sponsor ID
- 20-090
- Conditions
- Relapse, Quality of Life, Complication, Pain, Postoperative
- Keywords
- Ingrown nail, Simple surgery, Surgery with chemical cauterisation, Trichloroacetic acid, Relapse, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dermatologic intervention | Experimental | Procedure: Ingrown toenails with surgery with chemical cauterisationSurgery with chemical cauterisation TCA |
| Orthopedic intervention | Active comparator | Procedure: Ingrown toenails with only surgeryOnly surgery |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of ingrown toenail
- Patient informed and with signed informed consent
Key exclusion criteria (4 listed)
- Medical history of ingrown toenail on the concerned nail
- Other nail disease
- Pregnancy
- Allergy to local anesthetic or to trichloroacetic acid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ingrown toenails with surgery with chemical cauterisationRemoval of the ingrown lateral part of the toenail and chemical cauterisation | Procedure or surgery | Dermatologic intervention |
| Ingrown toenails with only surgeryRemoval of the ingrown lateral part of the toenail with directed Healing pad | Procedure or surgery | Orthopedic intervention |
Primary outcome
Relapses
Time frame: one year
Relapses of ingrown toenail on the operated nail
4 secondary outcomes
Gain of quality of life
Time frame: Baseline and one month after the surgery
Complications
Time frame: At one week and one month after surgery
Pain on the nail
Time frame: Baseline, one week and one month after surgery
Time before restart sport
Time frame: Restart sport at one month yes/no
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pr DOMPMARTIN ANNE contact
Pr DOMPMARTIN ANNE study director
University Hospital, Caen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ingrown toenails with surgery with chemical cauterisation and Ingrown toenails with only surgery in people with Relapse and Quality of Life, run by University Hospital, Caen at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GASLAIN NICOLAS (0231272510, gaslain-n@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapses (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.