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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muhammad Fahad Ali, MBBS, MRCS | Contact | +923320601136 | joyafahad@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr Muhammad Fahad Ali, Mbbs | Pakistan Institute of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pakistan Institute of Medical Sciences | Recruiting | Islamabad | 29111 | Pakistan |
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| ID | Term |
|---|---|
| D009263 | Nails, Ingrown |
| ID | Term |
|---|---|
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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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
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| 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. |
|
| Weekly upto 30 days |
| Work loss days | Number of days patient is unable to resume normal activities/work. | Upto 30 days |