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Altering Toenail Biomechanic in Managing Ingrown Toenail.

Primary Purpose

Ingrown Toenail

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Central toenail resection

Wedge toenail resection

About this trial

This is an interventional treatment trial for Ingrown Toenail focused on measuring Ingrown toenail, Biomechanic, Central resection, Recurrence

Eligibility Criteria

10 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Central toenail resection

wedge toenail resection

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Postoperative pain on visual analog score for pain

All patients are pain free after 5 days postoperative

Intraoperative time measured in minutes

All operations end within 15 minutes.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03732313

First Posted

October 27, 2018

Last Updated

November 2, 2018

Sponsor

Zagazig University

1. Study Identification

Unique Protocol Identification Number

NCT03732313

Brief Title

Altering Toenail Biomechanic in Managing Ingrown Toenail.

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

January 1, 2017 (Actual)

Primary Completion Date

January 1, 2018 (Actual)

Study Completion Date

July 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ingrown Toenail

Keywords

Ingrown toenail, Biomechanic, Central resection, Recurrence

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Central toenail resection

Arm Type

Active Comparator

Arm Description

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.

Arm Title

wedge toenail resection

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Central toenail resection

Other Intervention Name(s)

Surgical resection

Intervention Description

Using local aneasthesia, resection of central part of toenail with germinal matrix.

Intervention Type

Procedure

Intervention Name(s)

Wedge toenail resection

Other Intervention Name(s)

Surgical resection

Intervention Description

Using local anaesthesia,we remove lateral part of toenail .

Primary Outcome Measure Information:

Title

Postoperative pain on visual analog score for pain

Description

All patients are pain free after 5 days postoperative

Time Frame

six month

Title

Intraoperative time measured in minutes

Description

All operations end within 15 minutes.

Time Frame

Six month

Secondary Outcome Measure Information:

Title

Recurrence after operation

Description

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.

Time Frame

six month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Altering Toenail Biomechanic in Managing Ingrown Toenail.

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