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

Primary Purpose

Injury Arm

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Flaps Coverage
Occlusive Dressing
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Injury Arm focused on measuring occlusive dressing

Eligibility Criteria

12 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of medicine Assiut University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Flaps Coverage

Occlusive Dressing

Arm Description

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.

Outcomes

Primary Outcome Measures

quick DASH score
A questionnaire consisting of eleven items that test the functional recovery following upper limb injury

Secondary Outcome Measures

The presence of nail deformity.
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
Pulp volume compared to the contralateral finger: on lateral X-ray
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
presence of painful neuroma
absent or present if present either affect patient function or not
Sensory related outcome in the form of Two point discrimination test (Weber index)
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
Finger length: expressed as a shortage in mm. compared to contralateral finger.
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

Full Information

First Posted
May 26, 2017
Last Updated
May 10, 2020
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03193983
Brief Title
V-Y Flap Versus Occlusive Dressing in Treating Fingertip Injuries With Exposed Bone
Official Title
V-Y Flap Versus Occlusive Dressing in Treating Fingertip Injuries With Exposed Bone
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injury Arm
Keywords
occlusive dressing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Flaps Coverage
Arm Type
Experimental
Arm Description
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.
Arm Title
Occlusive Dressing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Flaps Coverage
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Occlusive Dressing
Intervention Description
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 Measure Information:
Title
quick DASH score
Description
A questionnaire consisting of eleven items that test the functional recovery following upper limb injury
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The presence of nail deformity.
Description
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
Time Frame
6 months
Title
Pulp volume compared to the contralateral finger: on lateral X-ray
Description
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
Time Frame
6 months
Title
presence of painful neuroma
Description
absent or present if present either affect patient function or not
Time Frame
6 months
Title
Sensory related outcome in the form of Two point discrimination test (Weber index)
Description
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
Time Frame
6 months
Title
Finger length: expressed as a shortage in mm. compared to contralateral finger.
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: a. Inclusion criteria: Age Adults 12 - 60 years Diagnosis of fingertip injury with exposed bone (Allen type 2, 3 or 4) in any finger. 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.
Facility Information:
Facility Name
Faculty of medicine Assiut University
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
whole study data and results will be available

Learn more about this trial

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

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