Ingrowing Nail With InfectionNCT05062616
Patient Satisfaction After Ingrown Toenail Surgery
An observational study of Ingrowing Nail With Infection, run by Goztepe Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, demographic characteristics (age, gender, which toe is involved, family history) of the patients who were operated because of ingrown nails were examined, and the post-operative satisfaction score of the patients was noted, and the recurrence rate and complications were recorded. Read more about this study
- Who is it for?
- Ages 8 to 80 years
- Conditions the study is for
- Ingrowing Nail With Infection
- What is being tested?
- Toenail surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1,200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 20 Sep 2021
- Phase
- Observational
- 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 8 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who had ingrown toenail surgery between 8 and 80 years old.
Who may be able to join
- Patients who underwent ingrown toenail surgery Patients who could be reachable by phone over contact details on medical records
Who cannot join
- Patients who were not reachable Patients who underwent another surgery on the targeted foot rather than ingrown toenail surgery Patients who had fractures on the targeted foot Clinical diagnosis of Alzheimer disease or patients who have lost their cognitive functions.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Medeniyet University
Istanbul, Kadıköy, 34732
About this study
Official title: Patient Satisfaction After Ingrown Toenail Surgery. A Review of 1200 Cases
In this study, demographic characteristics (age, gender, which toe is involved, family history) of the patients who were operated because of ingrown nails were examined, and the post-operative satisfaction score of the patients was noted, and the recurrence rate and complications were recorded.
Read the detailed description
The study was designed as single-center, single-surgeon observational study. Approximately 4000 patients who were operated on by the same surgeon between 2015-2020 due to ingrown nails were reached by phone, and patients' satisfaction was assessed by using the Surgical Satisfaction Questionnaire (SSQ-8). Outcomes such as retrospective treatment processes and complications were asked using a questionnaire, and patients' demographic characteristics were also recorded.
- Conditions
- Ingrowing Nail With Infection
- Being tested
- Toenail surgery
- Keywords
- patient satisfaction, operative treatment, ingrown toenail, onychocryptosis
- Medical subject headings
- Patient Satisfaction, Nails, Ingrown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toenail surgeryProcedure or surgery
modified Winograd procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
The Surgical Satisfaction Questionnaire (SSQ-8)
SSQ-8 is a validated tool for the assessment of patients who had been operated on.
Measured: At least one year after surgery
Secondary outcomes (3)
Recurrence
Recurrence rate is noted
Measured: At least one year after surgery
The shape of nail clipping
straight or round cut
Measured: through study completion, an average of 2 years
Family history
Positive or negatif family history
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start1 May 2021
- Primary completion1 May 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ingrowing Nail With InfectionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goztepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esat UYGUR, Goztepe Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062616
- Sponsor's protocol ID
- 2021-03
- Status last verified
- Oct 2021
- First submitted
- 21 Sep 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction After Ingrown Toenail Surgery. A Review of 1200 Cases
- ClinicalTrials.gov ID
- NCT05062616
- Acronym / sponsor ID
- 2021-03
- Conditions
- Ingrowing Nail With Infection
- Keywords
- patient satisfaction, operative treatment, ingrown toenail, onychocryptosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Goztepe Training and Research HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 30 Sep 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.
In this study, demographic characteristics (age, gender, which toe is involved, family history) of the patients who were operated because of ingrown nails were examined, and the post-operative satisfaction score of the patients was noted, and the recurrence rate and complications were recorded.
Detailed description
The study was designed as single-center, single-surgeon observational study. Approximately 4000 patients who were operated on by the same surgeon between 2015-2020 due to ingrown nails were reached by phone, and patients' satisfaction was assessed by using the Surgical Satisfaction Questionnaire (SSQ-8). Outcomes such as retrospective treatment processes and complications were asked using a questionnaire, and patients' demographic characteristics were also recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 8 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who had ingrown toenail surgery between 8 and 80 years old.
Key inclusion criteria (1 listed)
- Patients who underwent ingrown toenail surgery Patients who could be reachable by phone over contact details on medical records
Key exclusion criteria (1 listed)
- Patients who were not reachable Patients who underwent another surgery on the targeted foot rather than ingrown toenail surgery Patients who had fractures on the targeted foot Clinical diagnosis of Alzheimer disease or patients who have lost their cognitive functions.
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 |
|---|---|---|
| Toenail surgerymodified Winograd procedure | Procedure or surgery | – |
Primary outcome
The Surgical Satisfaction Questionnaire (SSQ-8)
Time frame: At least one year after surgery
SSQ-8 is a validated tool for the assessment of patients who had been operated on.
3 secondary outcomes
Recurrence
Time frame: At least one year after surgery
The shape of nail clipping
Time frame: through study completion, an average of 2 years
Family history
Time frame: through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ingrowing Nail With Infection, run by Goztepe Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Surgical Satisfaction Questionnaire (SSQ-8) (time frame: At least one year after surgery). 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 19 Oct 2021.