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Completed

NCT Number: NCT03193983

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

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.

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Key information

Conditions

Injury Arm Arm Injuries Wounds and Injuries

Age range

12 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine Assiut University

Asyut, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flaps Coverage

Procedure

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.

Occlusive Dressing

Procedure

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 outcomes

  1. quick DASH score

    Time frame: 6 months

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 21, 2017
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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