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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-75
SponsorPakistan Institute of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients presenting with ingrown toenail (onychocryptosis)

Patients for whom surgical intervention is indicated

Age between 12 and 75 years

Both male and female participants

Disqualifiers

Patients with diabetes mellitus

Patients with peripheral vascular disease

Immunocompromised patients

Patients with coagulopathy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Winograd Technique

    Procedure/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) Method

    Procedure/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.

Treatment groups

312 Participants
are divided into 2 treatment groups
Group A: Winograd ProcedureExperimental treatment 1 intervention
Group B: Sleeve (Gutter) MethodExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
30 days

Secondary outcomes

1

Postoperative Infection

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

Time frame
30 days
2

Wound healing

Assessment of healing progression at the surgical site.

Time frame
Weekly upto 30 days
3

Work loss days

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

Time frame
Upto 30 days

Other outcomes

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