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

Injury Arm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03193983
• Other study ID #: AssiutUMAAFDD
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: May 2019

Study information

• Verified date: May 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Injury Arm
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of medicine Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quick DASH score	A questionnaire consisting of eleven items that test the functional recovery following upper limb injury	6 months
Secondary	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	6 months
Secondary	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	6 months
Secondary	presence of painful neuroma	absent or present if present either affect patient function or not	6 months
Secondary	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	6 months
Secondary	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	6 months