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

NCT07547241 | Recruiting

• 1 other identifier: FMTI ERBB/06/01
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ingrown Toenail (Onychocryptosis)

Keywords

IGTN; Ingrown nail; In-grown toe nail

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Postoperative Infection

  30 days

• Wound healing

  Weekly upto 30 days

• Work loss days

  Upto 30 days

Study Arms (2)

Winograd Procedure

EXPERIMENTAL

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

Sleeve (Gutter) Method

EXPERIMENTAL

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

Interventions

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.

Winograd Procedure

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.

Sleeve (Gutter) Method

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pakistan Institute of Medical Sciences: lead

Study Sites (1)

Pakistan Institute of Medical Sciences

Islamabad, 29111, Pakistan

RECRUITING

MeSH Terms

Conditions

Nails, Ingrown

Interventions

Methods

Condition Hierarchy (Ancestors)

Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Dr Muhammad Fahad Ali, Mbbs

  Pakistan Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Fahad Ali, MBBS, MRCS

CONTACT

+923320601136; joyafahad@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Muhammad Fahad Ali

Model Details: The sample was divided into two groupings (A and B) by manually drawing the subjects. Group A was subjected to the Winograd procedure which included longitudinal nail incision, removal of the lateral nail matrix and granulation tissue to periosteum and suture of nail fold. Group B was subjected to Sleeve (gutter) procedure, where the growing portion of proceeding nail and a thin strip of unchanged nail were excised and a flexible tube was inserted in the groove during 10-14 days. In case of granulation tissue, it was cauterized. The surgeries were conducted by trained residents but under the supervision of a consultant dermatologist in accordance with standardised procedures. There was no difference in postoperative management, such as analgesics and antibiotics. Patients in both groups were followed after every 1 week to examine the healing process and recurrence was record as per operational definition. Gathered observations were recorded and statistical analysed using the SPPS ver

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 23, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

PA (1)