Comparison of Two Surgical Methods (Winograd vs. Sleeve Method) in the Treatment of Ingrown Toenail.

COMPARISON OF TWO SURGICAL METHODS (WINOGRAD VS SLEEVE METHOD) IN THE TREATMENT OF INGROWN TOE NAIL

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.

Study Overview

• Status: Recruiting
• Conditions: Ingrown Toenail (Onychocryptosis)
• Intervention / Treatment: Procedure: Winograd Technique; Procedure: Sleeve (Gutter) Method

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 312
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muhammad Fahad Ali, MBBS, MRCS; Phone Number: +923320601136; Email: joyafahad@gmail.com

Study Locations

• Pakistan
  • Islamabad, Pakistan, 29111
    • Recruiting
    • Pakistan Institute of Medical Sciences
    • Contact: Muhammad Fahad Ali; Phone Number: +923320601136; Email: joyafahad@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Winograd Procedure; Surgical partial nail avulsion with excision of the lateral nail matrix and nail fold. A longitudinal incision is made along the ingrown nail edge, followed by wedge resection of the nail matrix and surrounding soft tissue. The wound is closed with sutures.	Procedure: Winograd Technique; Surgical partial nail avulsion with excision of the lateral nail matrix and nail fold. A longitudinal incision is made along the ingrown nail edge, followed by wedge resection of the nail matrix and surrounding soft tissue. The wound is closed with sutures.
Experimental: Sleeve (Gutter) Method; Partial removal of the ingrown nail edge followed by insertion of a flexible tube beneath the nail margin to separate it from the surrounding soft tissue and guide proper nail growth. Granulation tissue, if present, is removed.	Procedure: Sleeve (Gutter) Method; Partial removal of the ingrown nail edge followed by insertion of a flexible tube beneath the nail margin to separate it from the surrounding soft tissue and guide proper nail growth. Granulation tissue, if present, is removed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of Ingrown Toenail	Recurrence is defined as the presence of pain, erythema, edema, discharge, or need for medical or surgical re-intervention at the same nail site.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Infection	Presence of purulent discharge, redness, or need for antibiotics.	30 days
Wound healing	Assessment of healing progression at the surgical site.	Weekly upto 30 days
Work loss days	Number of days patient is unable to resume normal activities/work.	Upto 30 days

Collaborators and Investigators

• Sponsor: Pakistan Institute of Medical Sciences
• Investigators: Principal Investigator: Dr Muhammad Fahad Ali, Mbbs, Pakistan Institute of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Ingrown nail; IGTN; In-grown toe nail
• Additional Relevant MeSH Terms: Skin Diseases; Nail Diseases; Skin and Connective Tissue Diseases; Nails, Ingrown; Investigative Techniques; Methods
• Other Study ID Numbers: FMTI ERBB/06/01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No