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NCT Number: NCT07547241

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

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.

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Key information

Age range

12 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pakistan Institute of Medical Sciences

Islamabad, 29111, Pakistan

Location status: Recruiting

Location contact

Muhammad Fahad Ali

CONTACT

[email protected]

+923320601136

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Winograd Technique

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.

Sleeve (Gutter) Method

Procedure

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.

Primary outcomes

  1. Recurrence of Ingrown Toenail

    Time frame: 30 days

    Recurrence is defined as the presence of pain, erythema, edema, discharge, or need for medical or surgical re-intervention at the same nail site.

Secondary outcomes

  1. Postoperative Infection

    Time frame: 30 days

    Presence of purulent discharge, redness, or need for antibiotics.

  2. Wound healing

    Time frame: Weekly upto 30 days

    Assessment of healing progression at the surgical site.

  3. Work loss days

    Time frame: Upto 30 days

    Number of days patient is unable to resume normal activities/work.

Study contacts

Contact information is provided by the study sponsor or research team.

Muhammad Fahad Ali, MBBS, MRCS

CONTACT

[email protected]

+923320601136

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Medical Sciences

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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