Ingrown ToenailNCT03732313
Altering Toenail Biomechanic in Managing Ingrown Toenail.
A study testing Central toenail resection and Wedge toenail resection in people with Ingrown Toenail, run by Zagazig University.
Trial summary
Ingrown toenail is commonly met in clinical practice.treatment may be non-operative and operative treatment.operative trestment depends on lateral wedge resection of the nail. The idea is to change toenail biomechanics by central toenail resection. Read more about this study
- Who is it for?
- Ages 10 to 35 years
- Conditions the study is for
- Ingrown Toenail
- What is being tested?
- Central toenail resection and Wedge toenail resection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Jul 2018
- 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 10 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patient with ingrown toenail
- Patients from 10 years up to 35 years
Who cannot join
- patients with concurrent toe deformity
- patients less than 10 years or more than 35 years
About this study
Official title: Altering Toenail Biomechanic in Managing Ingrown Toenail.Randomized Clinical Trial.
Ingrown toenail is commonly met in clinical practice.treatment may be non-operative and operative treatment.operative trestment depends on lateral wedge resection of the nail. The idea is to change toenail biomechanics by central toenail resection.
Read the detailed description
The aim of this study is to compare between central toenail resection with ordinary lateral wedge resection in managing ingrown toenail. This study was performed on 100 patients divided into 2 groupd each is 50 patients. Group A underwent central resection while group B underwent lateral toenail resection.
- Conditions
- Ingrown Toenail
- Being tested
- Central toenail resection, Wedge toenail resection
- Keywords
- Ingrown toenail, Biomechanic, Central resection, Recurrence
- Medical subject headings
- Nails, Ingrown, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central toenail resectionProcedure or surgery
Also called Surgical resection
Using local aneasthesia, resection of central part of toenail with germinal matrix.
Wedge toenail resectionProcedure or surgery
Also called Surgical resection
Using local anaesthesia,we remove lateral part of toenail .
| Study group | Role | What they receive |
|---|---|---|
| Central toenail resection | Active comparator | Under local ring anaesthesua using xylocaine injection in base of big toe ,Surgical resection of the central part of toenail with underlying germinal matrix.the defect is sutures by prolene. Receives: Procedure: Central toenail resection |
| wedge toenail resection | Active comparator | Under local ring anaesthesiausing xylocaine injection around the base of big toe. Resect lateral wedge of toenail with removal of ingrown toenail and periungual skin. The wound is then sutured. Receives: Procedure: Wedge toenail resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain on visual analog score for pain
All patients are pain free after 5 days postoperative
Measured: six month
Intraoperative time measured in minutes
All operations end within 15 minutes.
Measured: Six month
Secondary outcomes (1)
Recurrence after operation
Recurrence is followed up by asking the patient to follow up in outpatient clinic after six month and also,by calling the patients in telephone.
Measured: six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start1 Jan 2017
- Primary completion1 Jan 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ingrown ToenailStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tamer Alsaied Alnaimy, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732313
- Sponsor's protocol ID
- 27908201300677
- Status last verified
- Nov 2018
- First submitted
- 27 Oct 2018
- Last updated
- 6 Nov 2018
- 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 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Altering Toenail Biomechanic in Managing Ingrown Toenail.Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03732313
- Acronym / sponsor ID
- 27908201300677
- Conditions
- Ingrown Toenail
- Keywords
- Ingrown toenail, Biomechanic, Central resection, Recurrence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 6 Nov 2018 (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 commonly met in clinical practice.treatment may be non-operative and operative treatment.operative trestment depends on lateral wedge resection of the nail. The idea is to change toenail biomechanics by central toenail resection.
Detailed description
The aim of this study is to compare between central toenail resection with ordinary lateral wedge resection in managing ingrown toenail. This study was performed on 100 patients divided into 2 groupd each is 50 patients. Group A underwent central resection while group B underwent lateral toenail resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Central toenail resection | Active comparator | Procedure: Central toenail resectionUnder local ring anaesthesua using xylocaine injection in base of big toe ,Surgical resection of the central part of toenail with underlying germinal matrix.the defect is sutures by prolene. |
| wedge toenail resection | Active comparator | Procedure: Wedge toenail resectionUnder local ring anaesthesiausing xylocaine injection around the base of big toe. Resect lateral wedge of toenail with removal of ingrown toenail and periungual skin. The wound is then sutured. |
Who may qualify
- Ages
- 10 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- patient with ingrown toenail
- Patients from 10 years up to 35 years
Key exclusion criteria (2 listed)
- patients with concurrent toe deformity
- patients less than 10 years or more than 35 years
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 |
|---|---|---|
| Central toenail resectionAlso: Surgical resectionUsing local aneasthesia, resection of central part of toenail with germinal matrix. | Procedure or surgery | Central toenail resection |
| Wedge toenail resectionAlso: Surgical resectionUsing local anaesthesia,we remove lateral part of toenail . | Procedure or surgery | wedge toenail resection |
Primary outcome
Postoperative pain on visual analog score for pain
Time frame: six month
All patients are pain free after 5 days postoperative
Intraoperative time measured in minutes
Time frame: Six month
All operations end within 15 minutes.
1 secondary outcome
Recurrence after operation
Time frame: six month
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 6 Nov 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Central toenail resection and Wedge toenail resection in people with Ingrown Toenail, run by Zagazig University.
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 2 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 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Postoperative pain on visual analog score for pain (time frame: six month). The study lists 2 primary outcomes in all. 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 6 Nov 2018.