Clinical trial NCT06862232: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ingrown Toenail
Keywords: ingrown toenail
birdflap surgery
winograd
recurrence
noel's surgery
Lead sponsor: Kutahya City Hospital
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Reccurence
timeFrame: six months
Secondary outcomes:
measure: Recovery Time
timeFrame: 6 months
measure: Complication
timeFrame: six months
measure: Life Qualty Assesment
timeFrame: six months
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kutahya City Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.