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Altering Toenail Biomechanic in Managing Ingrown Toenail.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03732313
Recruitment Status : Completed
First Posted : November 6, 2018
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Tamer Alsaied Alnaimy, Zagazig University

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.

Condition or disease Intervention/treatment Phase
Ingrown Toenail Procedure: Central toenail resection Procedure: Wedge toenail resection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Altering Toenail Biomechanic in Managing Ingrown Toenail.Randomized Clinical Trial.
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : July 1, 2018

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 Name: 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 Name: Surgical resection




Primary Outcome Measures :
  1. Postoperative pain on visual analog score for pain [ Time Frame: six month ]
    All patients are pain free after 5 days postoperative

  2. Intraoperative time measured in minutes [ Time Frame: Six month ]
    All operations end within 15 minutes.


Secondary Outcome Measures :
  1. Recurrence after operation [ Time Frame: six month ]
    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.



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Ages Eligible for Study:   10 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: Tamer Alsaied Alnaimy, Assistant professour general surgery zagazig university Egypt, Zagazig University
ClinicalTrials.gov Identifier: NCT03732313    
Other Study ID Numbers: 27908201300677
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tamer Alsaied Alnaimy, Zagazig University:
Ingrown toenail
Biomechanic
Central resection
Recurrence
Additional relevant MeSH terms:
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Nails, Ingrown
Nail Diseases
Skin Diseases