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V-Y Flap Versus Occlusive Dressing in Treating Fingertip Injuries With Exposed Bone

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ClinicalTrials.gov Identifier: NCT03193983
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Mohammed Abdelnasser Abdelfatah Farghay, Assiut University

Brief Summary:
Fingertip is a complex structure that is responsible for the fine function of the fingers and the whole hand. A fingertip injury is any soft tissue, nail or bony injury distal to the insertions of the long flexor and extensor tendons of a finger .Fingertip injury is a serious condition that if untreated properly could lead to significant functional disability and disuse of the injured finger. Up to date, defining the best treatment option for this injury remains controversial. Hand surgeons are divided between proponents of flap coverage and conservative treatment, driven by beliefs, training programs and financial aspects. After recently reviewing the literature for the current best evidence and fundamentals of conservative treatment, Krauss and Lalandei in their recent review of the literature, pointed out to the necessity for implementing controlled trials to compare both ways of treatment.

Condition or disease Intervention/treatment Phase
Injury Arm Procedure: Flaps Coverage Procedure: Occlusive Dressing Not Applicable

Detailed Description:

The purpose of this study is to determine the efficacy and the results of occlusive dressing in treating fingertip injuries in comparison to flaps with much concern to certain factors that are closely related to our locality including patient compliance for regular follow up , functional outcome , time to return to work and its socioeconomical impact and cosmetic results .

Surgical group will undergo surgical coverage of the fingertip defect by V-Y flap using the skin on the volar aspect of the same finger designed as V shaped then mobilized dorsally to cover the defect and stitches to be Y shaped. Stitches are removed after 2 weeks.

Conservative group will undergo minimal trimming of the bone end and an occlusive dressing that is changed on a weekly basis till complete healing of the defect that occurs after 6 weeks


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

two groups Surgical group will undergo surgical coverage of the fingertip defect by V-Y flap using the skin on the volar aspect of the same finger designed as V shaped then mobilized dorsally to cover the defect and stitches to be Y shaped. Stitches are removed after 2 weeks.

Conservative group will undergo minimal trimming of the bone end and an occlusive dressing that is changed on a weekly basis till complete healing of the defect that occurs after 6 weeks.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: V-Y Flap Versus Occlusive Dressing in Treating Fingertip Injuries With Exposed Bone
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Arm Intervention/treatment
Experimental: Flaps Coverage
Surgical group will undergo surgical coverage of the fingertip defect by V-Y flap using the skin on the volar aspect of the same finger designed as V shaped then mobilized dorsally to cover the defect and stitches to be Y shaped. Stitches are removed after 2 weeks.
Procedure: Flaps Coverage
Surgical group will undergo surgical coverage of the fingertip defect by V-Y flap using the skin on the volar aspect of the same finger designed as V shaped then mobilized dorsally to cover the defect and stitches to be Y shaped. Stitches are removed after 2 weeks.

Experimental: Occlusive Dressing
Conservative group will undergo minimal trimming of the bone end and an occlusive dressing that is changed on a weekly basis till complete healing of the defect that occurs after 6 weeks.
Procedure: Occlusive Dressing
Conservative group will undergo minimal trimming of the bone end and an occlusive dressing that is changed on a weekly basis till complete healing of the defect that occurs after 6 weeks.




Primary Outcome Measures :
  1. quick DASH score [ Time Frame: 6 months ]
    A questionnaire consisting of eleven items that test the functional recovery following upper limb injury


Secondary Outcome Measures :
  1. The presence of nail deformity. [ Time Frame: 6 months ]
    any nail deformity will be reported the most common is hook nail deformity and then the deformity wiil be classified according to the severity to mild moderate and severe

  2. Pulp volume compared to the contralateral finger: on lateral X-ray [ Time Frame: 6 months ]
    either no decrease in the pulp volume or decreased to less than the half compared to the contralateral finger or more than the half compared to the contralateral finger

  3. presence of painful neuroma [ Time Frame: 6 months ]
    absent or present if present either affect patient function or not

  4. Sensory related outcome in the form of Two point discrimination test (Weber index) [ Time Frame: 6 months ]
    measurement and classification of Two point discrimination can be done by Touch-Test 2-Point Discriminator which consists of two sturdy, rotating, plastic disks that are joined together.Rounded tips are spaced at standard testing intervals from 1 to 15 mm apart. A 20 and 25 mm spacing also are given. One disk setting tests from 1 to 8mm, and the other setting tests from 9 to 15 mm. To change settings, just rotate the top disk until it clicks in place

  5. Finger length: expressed as a shortage in mm. compared to contralateral finger. [ Time Frame: 6 months ]
    the shortage is classified to three items a) no shortage b) less half compared to contralateral finger and c) more than compared to contralateral finger



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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a. Inclusion criteria:

    1. Age Adults 12 - 60 years
    2. Diagnosis of fingertip injury with exposed bone (Allen type 2, 3 or 4) in any finger.
    3. Informed consent obtained by the patient.

Exclusion Criteria:

  • · Old or complicated fingertip injuries.

    • Non-exposed bone fingertip injury (Allen type1).
    • Patients with severe debilitating disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193983


Contacts
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Contact: Mohammed Farghaly, resident doctor +201060643674 mohammedabdelnasserdd1991@gmail.com
Contact: Amr Fargaly 01026998463 mucosa_1991@yahoo.com

Locations
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Egypt
Faculty of medicine Assiut University Recruiting
Assiut, Egypt
Sponsors and Collaborators
Assiut University

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Responsible Party: Mohammed Abdelnasser Abdelfatah Farghay, Assiut University , resident doctor at orthopedic and trauma department assiut university hospital, Assiut University
ClinicalTrials.gov Identifier: NCT03193983     History of Changes
Other Study ID Numbers: AssiutUMAAFDD
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: whole study data and results will be available

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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 Mohammed Abdelnasser Abdelfatah Farghay, Assiut University:
occlusive dressing

Additional relevant MeSH terms:
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Wounds and Injuries