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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06862232
Acronym
ITN
Enrollment
108
Registered
2025-03-06
Start date
2025-03-01
Completion date
2025-12-01
Last updated
2025-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ingrown Toenail

Keywords

ingrown toenail, birdflap surgery, winograd, recurrence, noel's surgery

Brief 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. 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.

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.

Interventions

PROCEDUREModified Winograd Bird Flap Technique

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.

PROCEDUREClassic Winograd Technique

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.

PROCEDUREModified Noel Technique

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.

Sponsors

Kutahya City Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

To further minimize potential bias, the decision regarding the necessity of surgical intervention will be made by a surgeon independent of the study investigator. This ensures that the operating surgeon does not influence patient selection or determine which surgical technique is applied to each patient. All postoperative outcomes, including recurrence rates, complications, pain levels, and functional recovery, will be assessed by a separate independent, blinded evaluator, ensuring an objective assessment of surgical efficacy.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Reccurencesix monthsThe 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.

Secondary

MeasureTime frameDescription
Recovery Time6 monthsTime to Resume Wearing Normal Footwear and Return to Work Duration
Complicationsix monthsSevere pain, infection, bleeding, or wound care complications requiring hospital or physician intervention.
Life Qualty Assesmentsix monthsAssessment 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactBilgehan Ocak, MD
bilgeocak@gmail.com+90 5377374534
Backup ContactTuran Cİhan Dulgeroglu, Prof
dr_turancihan@hotmail.com+90 505 834 67 53

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026