Overview
This randomized clinical trial aims to compare the recurrence rates of two surgical techniques-Winograd procedure and sleeve (gutter) method-in the treatment of ingrown toenails (onychocryptosis). A total of 312 nails will be randomized into two groups, with patients receiving either the Winograd procedure or sleeve method. Participants will be followed for 30 days post-intervention to assess recurrence and other clinical outcomes. The study seeks to determine the more effective treatment modality for reducing recurrence in a tertiary care setting.
Description
ngrown toenail (onychocryptosis) is a common and painful condition characterized by the penetration of the nail plate into the surrounding soft tissue, resulting in inflammation, infection, and impaired daily function. It most frequently affects the great toe and can significantly impact quality of life. While both conservative and surgical treatment options exist, recurrence remains a major concern.
Among surgical interventions, the Winograd procedure is a commonly used technique involving partial nail avulsion with excision of the nail matrix, offering a more definitive solution. In contrast, the sleeve (gutter) method is a minimally invasive technique that involves insertion of a tube beneath the nail edge to prevent soft tissue impingement and guide proper nail growth.
Despite widespread use of both techniques, there is no clear consensus regarding their comparative effectiveness, particularly in terms of recurrence rates. Furthermore, there is a lack of locally generated evidence to guide clinical decision-making in our population.
This study will be conducted as a randomized clinical trial in the Department of General Surgery at a tertiary care hospital. A total of 312 patients meeting inclusion criteria will be enrolled and allocated into two equal groups using a lottery method. Group A will undergo the Winograd procedure, while Group B will be treated with the sleeve method.
All procedures will be performed under standardized conditions by trained surgical residents under supervision. Patients will receive uniform postoperative care, including analgesics and antibiotics. Follow-up will be conducted weekly for 30 days to assess healing and detect recurrence.
The primary outcome will be recurrence of ingrown toenail, defined clinically by pain, inflammation, discharge, or need for re-intervention at the same site. Secondary observations may include infection, healing status, and functional recovery.
The findings of this study are expected to provide evidence-based guidance for selecting the optimal surgical technique for ingrown toenail, particularly in resource-limited settings, and may contribute to improved patient outcomes and standardization of care.
Eligibility
Inclusion Criteria:
- Patients presenting with ingrown toenail (onychocryptosis)
- Patients for whom surgical intervention is indicated
- Age between 12 and 75 years
- Both male and female participants
- Patients willing to provide informed consent
Exclusion Criteria:
- Patients with diabetes mellitus
- Patients with peripheral vascular disease
- Immunocompromised patients
- Patients with coagulopathy
- Patients receiving chemotherapy
- Patients with localized infection or abscess at the surgical site
- Patients with previously treated or recurrent ingrown toenail
- Patients presenting with delayed complications of prior ingrown toenail surgery
