Altering Toenail Biomechanic in Managing Ingrown Toenail.

Altering Toenail Biomechanic in Managing Ingrown Toenail.Randomized Clinical Trial.

Ingrown toenail is commonly met in clinical practice.treatment may be non-operative and operative treatment.operative trestment depends on lateral wedge resection of the nail. The idea is to change toenail biomechanics by central toenail resection.

Study Overview

• Status: Completed
• Conditions: Ingrown Toenail
• Intervention / Treatment: Procedure: Central toenail resection; Procedure: Wedge toenail resection

Detailed Description

The aim of this study is to compare between central toenail resection with ordinary lateral wedge resection in managing ingrown toenail. This study was performed on 100 patients divided into 2 groupd each is 50 patients. Group A underwent central resection while group B underwent lateral toenail resection.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 33 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patient with ingrown toenail
• Patients from 10 years up to 35 years

Exclusion Criteria:

• patients with concurrent toe deformity
• patients less than 10 years or more than 35 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Central toenail resection; Under local ring anaesthesua using xylocaine injection in base of big toe ,Surgical resection of the central part of toenail with underlying germinal matrix.the defect is sutures by prolene.	Procedure: Central toenail resection; Using local aneasthesia, resection of central part of toenail with germinal matrix.; Other Names: Surgical resection
Active Comparator: wedge toenail resection; Under local ring anaesthesiausing xylocaine injection around the base of big toe. Resect lateral wedge of toenail with removal of ingrown toenail and periungual skin. The wound is then sutured.	Procedure: Wedge toenail resection; Using local anaesthesia,we remove lateral part of toenail .; Other Names: Surgical resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain on visual analog score for pain	All patients are pain free after 5 days postoperative	six month
Intraoperative time measured in minutes	All operations end within 15 minutes.	Six month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence after operation	Recurrence is followed up by asking the patient to follow up in outpatient clinic after six month and also,by calling the patients in telephone.	six month

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: October 27, 2018
• First Submitted That Met QC Criteria: November 2, 2018
• First Posted (Actual): November 6, 2018

Study Record Updates

• Last Update Posted (Actual): November 6, 2018
• Last Update Submitted That Met QC Criteria: November 2, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Recurrence; Ingrown toenail; Biomechanic; Central resection
• Additional Relevant MeSH Terms: Skin Diseases; Nail Diseases; Nails, Ingrown
• Other Study ID Numbers: 27908201300677

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No