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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKutahya City Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age between 18 and 65 years

Diagnosis of ingrown toenail (onychocryptosis)

Indication for surgical treatment

Disqualifiers

Presence of malignancy in the body

Existence of foot deformities

Presence of pincer nail deformity

History of drug allergy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Modified Winograd "Bird Flap" Technique

    Procedure/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 Technique

    Procedure/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 Technique

    Procedure/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.

Treatment groups

108 Participants
are divided into 3 treatment groups
Group A: Modified Winograd "Bird Flap" TechniqueExperimental treatment 1 intervention
Group B: Modified Noel TechniqueActive comparator 1 intervention
Group C: Classic Winograd TechniqueActive comparator 1 intervention

Trial outcomes

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.

Time frame
six months

Secondary outcomes

1

Recovery Time

Time to Resume Wearing Normal Footwear and Return to Work Duration

Time frame
6 months
2

Complication

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

Time frame
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.

Time frame
six months

Other outcomes

Sponsors and contacts

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