Efficacy and Outcomes of Winograd, Birdflap, and Noel's Surgical Techniques in Ingrown Toenail Treatment: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Reccurence
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 65 years
- •Diagnosis of ingrown toenail (onychocryptosis)
- •Indication for surgical treatment
排除标准
- •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
结局指标
主要结局
Reccurence
时间窗: 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.
次要结局
- Recovery Time(6 months)
- Complication(six months)
- Life Qualty Assesment(six months)
研究者
Bilgehan OCAK
Principal Investigator
Kutahya City Hospital