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.

Study Overview

• Status: Completed
• Conditions: Injury Arm
• Intervention / Treatment: Procedure: Flaps Coverage; Procedure: Occlusive Dressing

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: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quick DASH score	A questionnaire consisting of eleven items that test the functional recovery following upper limb injury	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
presence of painful neuroma	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)	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.	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

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: May 26, 2017
• First Submitted That Met QC Criteria: June 19, 2017
• First Posted (Actual): June 21, 2017

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 10, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: occlusive dressing
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID 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