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

May 10, 2020 updated by: Mohammed Abdelnasser Abdelfatah Farghay, Assiut University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Faculty of Medicine Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
quick DASH score
Time Frame: 6 months
A questionnaire consisting of eleven items that test the functional recovery following upper limb injury
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
6 months
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
6 months
presence of painful neuroma
Time Frame: 6 months
absent or present if present either affect patient function or not
6 months
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
6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AssiutUMAAFDD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

whole study data and results will be available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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