Ingrown Toenail (Onychocryptosis)NCT07547241
Comparison of Two Surgical Methods (Winograd vs. Sleeve Method) in the Treatment of Ingrown Toenail.
A study testing Winograd Technique and Sleeve (Gutter) Method in people with Ingrown Toenail (Onychocryptosis), run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Ingrown Toenail (Onychocryptosis)
- What is being tested?
- Winograd Technique and Sleeve (Gutter) Method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Pakistan Institute of Medical Sciences
Islamabad, 29111
Muhammad Fahad Ali, +923320601136, joyafahad@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Ingrown Toenail (Onychocryptosis)
- Being tested
- Winograd Technique, Sleeve (Gutter) Method
- Keywords
- IGTN, Ingrown nail, In-grown toe nail
- Medical subject headings
- Nails, Ingrown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Winograd TechniqueProcedure or surgery
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) MethodProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Sleeve (Gutter) Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (3)
Postoperative Infection
Presence of purulent discharge, redness, or need for antibiotics.
Measured: 30 days
Wound healing
Assessment of healing progression at the surgical site.
Measured: Weekly upto 30 days
Work loss days
Number of days patient is unable to resume normal activities/work.
Measured: Upto 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start1 Jun 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ingrown Toenail (Onychocryptosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammad Fahad Ali, Pakistan Institute of Medical Sciences
- Investigators
- Dr Muhammad Fahad Ali, Mbbs, Principal investigator, Pakistan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07547241
- Sponsor's protocol ID
- FMTI ERBB/06/01
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF TWO SURGICAL METHODS (WINOGRAD VS SLEEVE METHOD) IN THE TREATMENT OF INGROWN TOE NAIL
- ClinicalTrials.gov ID
- NCT07547241
- Acronym / sponsor ID
- FMTI ERBB/06/01
- Conditions
- Ingrown Toenail (Onychocryptosis)
- Keywords
- IGTN, Ingrown nail, In-grown toe nail
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Winograd Procedure | Experimental | Procedure: Winograd TechniqueSurgical 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 | Procedure: Sleeve (Gutter) MethodPartial 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. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Patients with diabetes mellitus
- Patients with peripheral vascular disease
- Immunocompromised patients
- Patients with coagulopathy
- Patients receiving chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Winograd TechniqueSurgical 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 or surgery | Winograd Procedure |
| Sleeve (Gutter) MethodPartial 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 or surgery | Sleeve (Gutter) Method |
Primary outcome
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.
3 secondary outcomes
Postoperative Infection
Time frame: 30 days
Wound healing
Time frame: Weekly upto 30 days
Work loss days
Time frame: Upto 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Muhammad Fahad Ali, Mbbs principal investigator
Pakistan Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Winograd Technique and Sleeve (Gutter) Method in people with Ingrown Toenail (Onychocryptosis), run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Fahad Ali, MBBS, MRCS (+923320601136, joyafahad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of Ingrown Toenail (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.