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

NCT06862232 | Not Yet Recruiting DMC

• 1 other identifier: KutahyaCH
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Ingrown Toenail

Keywords

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

Outcome Measures

Primary Outcomes (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.

  six months

Secondary Outcomes (3)

• Recovery Time

  6 months

• Complication

  six months

• Life Qualty Assesment

  six months

Study Arms (3)

Modified Winograd "Bird Flap" Technique

EXPERIMENTAL

Modified 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.

Procedure: Modified Winograd "Bird Flap" Technique

Modified Noel Technique

ACTIVE COMPARATOR

Modified 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.

Procedure: Modified Noel Technique

Classic Winograd Technique

ACTIVE COMPARATOR

Classic 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.

Procedure: Classic Winograd Technique

Interventions

Modified Winograd "Bird Flap" Technique PROCEDURE

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.

Modified Winograd "Bird Flap" Technique

Classic Winograd Technique PROCEDURE

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.

Classic Winograd Technique

Modified Noel Technique PROCEDURE

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.

Modified Noel Technique

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kutahya City Hospital: lead

Study Sites (1)

Kutahya City Hospital

Kütahya, 43040, Turkey (Türkiye)

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Nails, Ingrown; Recurrence

Condition Hierarchy (Ancestors)

Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Bilgehan Ocak, MD

CONTACT

+90 5377374534; bilgeocak@gmail.com

Turan Cİhan Dulgeroglu, Prof

CONTACT

+90 505 834 67 53; dr_turancihan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 6, 2025
• Study Start: March 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: it will be available as long as study goes on
• Access Criteria: all researchers https://five.epicollect.net/myprojects/my-thesis-about-ingrown-toenail

Locations

TU (1)