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

Not Applicable

Not yet recruiting

• Conditions: Ingrown Toenail

• Registration Number: NCT06862232
• Lead Sponsor: Kutahya City Hospital

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.

Study Timeline

• Study First Submitted: 2025-02-25
• Status Verified: 2025-03
• Study Start: 2025-03-01
• Study First Submitted QC: 2025-03-02
• Last Update Submitted: 2025-03-02
• Study First Posted: 2025-03-06
• Last Update Posted: 2025-03-06
• Primary Completion: 2025-11-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reccurence	six months	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.

Secondary Outcome Measures

Name	Time	Method
Recovery Time	6 months	Time to Resume Wearing Normal Footwear and Return to Work Duration
Complication	six months	Severe pain, infection, bleeding, or wound care complications requiring hospital or physician intervention.
Life Qualty Assesment	six months	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.

Trial Locations

Locations (1)

Kutahya City Hospital; 🇹🇷 Kütahya, Turkey