NCT03732313

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
Last Updated

November 6, 2018

Status Verified

November 1, 2018

Enrollment Period

1 year

First QC Date

October 27, 2018

Last Update Submit

November 2, 2018

Conditions

Ingrown Toenail

Keywords

Ingrown toenailBiomechanicCentral resectionRecurrence

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Recurrence after operation

    six month

Study Arms (2)

Central toenail resection

ACTIVE COMPARATOR

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

wedge toenail resection

ACTIVE COMPARATOR

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

Interventions

Central toenail resectionPROCEDURE

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

Also known as: Surgical resection
Central toenail resection
Wedge toenail resectionPROCEDURE

Using local anaesthesia,we remove lateral part of toenail .

Also known as: Surgical resection
wedge toenail resection

Eligibility Criteria

Age10 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Nails, IngrownRecurrence

Condition Hierarchy (Ancestors)

Nail DiseasesSkin DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professour general surgery zagazig university Egypt

Study Record Dates

First Submitted

October 27, 2018

First Posted

November 6, 2018

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

July 1, 2018

Last Updated

November 6, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share