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

Official title

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

Overview

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

• Procedure Modified 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
• Procedure Classic 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 sta
• Procedure Modified 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 pro

Primary outcome measures

• Reccurence [Time frame: six months]

Secondary outcome measures (3)

• Recovery Time [Time frame: 6 months]
• Complication [Time frame: six months]
• Life Qualty Assesment [Time frame: six months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Kutahya City Hospital — Kütahya

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. PMID 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. PMID 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. PMID 28190555

Identifiers

NCT: NCT06862232 · KutahyaCH

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗