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Ingrown ToenailITNNCT06862232

P : Ingrown Toenail Patient I : Bird Flap Surgery C : Noel Winograd Method O : Recurrence, Complications, Functional Outcome, Pain,

A study testing Modified Winograd "Bird Flap" Technique, Classic Winograd Technique and Modified Noel Technique in people with Ingrown Toenail, run by Kutahya City Hospital at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The treatment of ingrown toenails is highly diverse, with numerous surgical techniques described in the literature alongside conservative approaches. The primary goals of all these surgical methods are to reduce recurrence rates, improve patients' quality of life, and achieve favorable cosmetic outcomes. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Ingrown Toenail
What is being tested?
Modified Winograd "Bird Flap" Technique, Classic Winograd Technique and Modified Noel Technique
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2025to 1 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age between 18 and 65 years
  • Diagnosis of ingrown toenail (onychocryptosis)
  • Indication for surgical treatment

Who cannot join

  • Presence of malignancy in the body
  • Existence of foot deformities
  • Presence of pincer nail deformity
  • History of drug allergy
  • Presence of active infection in the body
  • Diabetic neuropathy or necrotic foot ulcers
  • Pregnancy
  • History of prior foot or ankle surgery

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Bilgehan Ocak, MD contact

+90 5377374534

bilgeocak@gmail.com

Turan Cİhan Dulgeroglu, Prof contact

+90 505 834 67 53

dr_turancihan@hotmail.com

Turkey (Türkiye)1 site
  • Kutahya City Hospital

    Kütahya, 43040

Other trials in Turkey (Türkiye)

About this study

Official title: Efficacy and Outcomes of Winograd, Birdflap, and Noel's Surgical Techniques in Ingrown Toenail Treatment: A Prospective Randomized Controlled Study

The treatment of ingrown toenails is highly diverse, with numerous surgical techniques described in the literature alongside conservative approaches. The primary goals of all these surgical methods are to reduce recurrence rates, improve patients' quality of life, and achieve favorable cosmetic outcomes. In this study, we aim to compare the recently introduced Bird Flap, a modified Winograd technique, with Noel's technique and the classic Winograd method in terms of recurrence rates, patient quality of life, cosmetic outcomes, and postoperative pain.

Read the detailed description

Comparison of Surgical Techniques for Medially Ingrown Toenails: A Prospective Randomized Study

Introduction:

Medially ingrown toenail (Onychocryptosis) is a common foot condition that significantly affects patients by causing pain and discomfort, particularly while walking or wearing shoes. The condition is characterized by localized inflammation and bacterial infection around the nail bed, leading to purulent discharge. Patients with ingrown toenails are classified using the Hefetz classification system.

The treatment options for ingrown toenails are diverse, including both conservative and surgical approaches. The primary objectives of surgical interventions are to reduce recurrence rates, improve patient quality of life, and achieve optimal cosmetic outcomes. In this study, we aimed to compare the recently introduced Bird Flap (a modified Winograd technique), Noel's technique, and the classic Winograd method in terms of recurrence rates, patient-reported quality of life, cosmetic appearance, and postoperative pain.

Methods:

This study included three different surgical techniques applied to three separate patient groups.

  • Group 1 (n=36): Patients underwent the modified Winograd "Bird Flap" technique, which involves an incision resembling the contour of a sparrow's body. Through this approach, the lateral nail bed, proximal germinal matrix, and granulation/infected tissue down to the bone were excised and subsequently sutured using prolene.
  • Group 2 (n=36): Patients underwent the modified Noel technique, which involved a 4-6 mm semi-elliptical incision adjacent to the lateral margins of the nail bed, targeting the granulated tissue. Unlike the Bird Flap technique, this approach preserved the nail bed and proximal germinal matrix, with only the inflamed soft tissue and granulated tissue excised. The wound was then sutured subungually using prolene.
  • Group 3 (n=36): Patients underwent the classic Winograd technique, which is the traditional method for ingrown toenail surgery. A linear incision was made to separate the nail bed from the soft tissue, followed by excision of the lateral edge of the nail bed and the germinal matrix in a linear fashion. The wound was then sutured accordingly.

Postoperative Follow-up and Outcome Measures:

All patients had their sutures removed on postoperative day 20 and were evaluated at 1-month, 2-month, and 3-month follow-ups.

  • Primary Outcome: Recurrence rate
  • Secondary Outcomes: Healing time, complications (bleeding, infection, wound site problems), and overall recovery and personal cosmetic satisfaction
  • Pain, functional impact, and quality of life were assessed using the European Quality of Life Instrument (EuroQol) test.

This structured comparison provides insight into the effectiveness of these three distinct surgical approaches in managing medially ingrown toenails, with an emphasis on clinical and patient-centered outcomes.

Conditions
Ingrown Toenail
Being tested
Modified Winograd "Bird Flap" Technique, Classic Winograd Technique, Modified Noel Technique
Keywords
ingrown toenail, birdflap surgery, winograd, recurrence, noel's surgery
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.

  • Modified Winograd "Bird Flap" TechniqueProcedure or surgery

    In the first group (n=36), the modified Winograd "Bird Flap" technique will be performed for medially ingrown toenails. Local anesthesia with 1% lidocaine will be administered at the base of the first toe, and a temporary tourniquet will be applied using a sterile glove to minimize bleeding.

    This technique modifies the Winograd method, optimizing functional and cosmetic outcomes while reducing recurrence rates. A sparrow-shaped incision will be made, encompassing the lateral nail bed, proximal germinal matrix, and underlying bone tissue, improving surgical access while preserving the healthy nail structure.

    Granulated and infected tissue will be excised completely down to the periosteum to prevent recurrence. The wound will be sutured using 3/0 prolene sutures, ensuring optimal healing and minimal scarring. This method aims to reduce pain, shorten recovery time, and improve patient satisfaction compared to traditional approaches.

  • Classic Winograd TechniqueProcedure or surgery

    The classic Winograd technique, a widely used traditional surgical approach, will be performed. Local anesthesia with 1% lidocaine will be administered, and a temporary tourniquet will be applied. A linear incision will be made to separate the nail bed from the soft tissue, followed by the excision of the lateral nail bed and germinal matrix in a linear fashion to ensure complete removal of the affected nail portion. The wound will then be sutured using 3/0 prolene sutures.

    This method is a standard approach for ingrown toenail surgery, offering high recurrence prevention rates but carrying a risk of cosmetic and structural nail alterations.

  • Modified Noel TechniqueProcedure or surgery

    Local anesthesia with 1% lidocaine will be administered, and a temporary tourniquet will be applied. A 4-6 mm semi-elliptical incision will be made adjacent to the lateral borders of the nail bed to access the granulated tissue.

    Unlike the Bird Flap technique, this method preserves both the nail bed and proximal germinal matrix, ensuring that only the inflamed soft tissue and granulated tissue are excised. The remaining tissue will be sutured subungually using 3/0 prolene sutures, promoting proper healing and maintaining the nail's structural integrity. This technique is designed to be less invasive while effectively treating infected and inflamed tissue.

Study groups in NCT06862232
Study groupRoleWhat they receive
Modified Winograd "Bird Flap" TechniqueExperimentalModified Winograd "Bird Flap" Technique In the first group (n=36), the modified Winograd "Bird Flap" technique will be performed. Local anesthesia will be administered using a 1% lidocaine solution, applied at the base of the first toe, and a temporary tourniquet will be placed using a sterile glove. The procedure involves creating an incision resembling the contour of a sparrow's body, extending over the lateral nail bed and reaching the proximal germinal matrix and underlying bone tissue. The granulated and infected tissue will be excised entirely to ensure complete removal of the affected area. The wound will then be sutured using 3/0 prolene sutures to achieve optimal wound closure. This technique aims to preserve the nail bed while effectively addressing the recurrence risk associated with conventional Winograd procedures.
Receives: Procedure: Modified Winograd "Bird Flap" Technique
Modified Noel TechniqueActive comparatorModified Noel Technique In the second group (n=36), the modified Noel technique will be utilized. Following local anesthesia with 1% lidocaine solution and the application of a temporary tourniquet, an approximately 4-6 mm semi-elliptical incision will be made adjacent to the lateral borders of the nail bed to access the granulated tissue. Unlike the Bird Flap technique, this method preserves both the nail bed and the proximal germinal matrix, ensuring that only the inflamed soft tissue and granulated tissue are excised. The remaining tissue will be sutured subungually using 3/0 prolene sutures to facilitate proper healing and maintain the structural integrity of the nail. This technique is designed to minimize invasiveness while effectively managing infected and inflamed tissue.
Receives: Procedure: Modified Noel Technique
Classic Winograd TechniqueActive comparatorClassic Winograd Technique In the third group (n=36), the classic Winograd technique, a widely used traditional surgical approach, will be performed. After administering 1% lidocaine solution for local anesthesia and applying a temporary tourniquet, a linear incision will be made to separate the nail bed from the soft tissue. The lateral edge of the nail bed and the germinal matrix will then be excised in a linear fashion, ensuring complete removal of the affected nail portion. The wound will subsequently be sutured using 3/0 prolene sutures. This method has been a standard approach for ingrown toenail surgery and is associated with high recurrence prevention rates but also carries a risk of cosmetic and structural alterations in the nail.
Receives: Procedure: Classic Winograd Technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reccurence

    The regrowth of the toenail towards the skin and/or soft tissue, leading to the recurrence of preoperative symptoms, characterized by pain, inflammation, and discomfort, occurring at any time within the first six months postoperatively.

    Measured: six months

Secondary outcomes (3)
  1. Recovery Time

    Time to Resume Wearing Normal Footwear and Return to Work Duration

    Measured: 6 months

  2. Complication

    Severe pain, infection, bleeding, or wound care complications requiring hospital or physician intervention.

    Measured: six months

  3. Life Qualty Assesment

    Assessment of Pain, Functional Status, and Quality of Life using the EuroQol 5-Dimension 5-Level Scale (EQ-5D-5L). The EQ-5D-5L index score ranges from 0 to 1.000, with higher scores indicating better quality of life. Assessments will be conducted at 1-month, 2-month,3 months and 6-month follow-ups.

    Measured: six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2025
  2. Study start1 Mar 2025 (estimated)
  3. Primary completion1 Nov 2025 (estimated)
  4. Study completion1 Dec 2025 (estimated)

Resources

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
Model description
The study is designed as a parallel-group, randomized controlled trial, consisting of three independent groups, each undergoing a different surgical technique for the treatment of medially ingrown toenails. Patients will be assigned to one of the three groups using a pre-generated randomized allocation list, ensuring an unbiased distribution. Each group will receive only the designated surgical intervention, with no crossover between groups. The surgical procedures will be performed according to the assigned technique, and postoperative outcomes-including recurrence rates, complications, pain levels, and functional recovery-will be assessed by an independent, blinded evaluator, ensuring objectivity and minimizing potential bias in outcome assessment.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06862232
Sponsor's protocol ID
KutahyaCH
Acronym
ITN
Status last verified
Mar 2025
First submitted
25 Feb 2025
Last updated
6 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All participant will be share in epicollect5 and take all personal information and take a photo of toenail in both coronal and axial view

Publications

  • Shang X, Jin Y, Meng X, Zhu H, Sun X, Xue Y, Rui Y. A novel modified Winograd surgical tricks and tips with a "bird flap" for the treatment of ingrown toenails. Foot Ankle Surg. 2023 Jun;29(4):361-366. doi: 10.1016/j.fas.2023.03.004. Epub 2023 Mar 15.

    PubMed 36964004
  • Dabrowski M, Litowinska A. Recurrence and satisfaction with sutured surgical treatment of an ingrown toenail. Ann Med Surg (Lond). 2020 Jun 26;56:152-160. doi: 10.1016/j.amsu.2020.06.029. eCollection 2020 Aug.

    PubMed 32637092
  • Livingston MH, Coriolano K, Jones SA. Nonrandomized assessment of ingrown toenails treated with excision of skinfold rather than toenail (NAILTEST): An observational study of the Vandenbos procedure. J Pediatr Surg. 2017 May;52(5):832-836. doi: 10.1016/j.jpedsurg.2017.01.029. Epub 2017 Jan 29.

    PubMed 28190555

Questions about this trial

What is this clinical trial studying?

A study testing Modified Winograd "Bird Flap" Technique, Classic Winograd Technique and Modified Noel Technique in people with Ingrown Toenail, run by Kutahya City 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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 6 Mar 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bilgehan Ocak, MD (+90 5377374534, bilgeocak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reccurence (time frame: six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06862232, which also lists 3 linked publications.

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 Mar 2025.

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