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

NCT03193983 | Completed

• 1 other identifier: AssiutUMAAFDD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Injury Arm

Keywords

occlusive dressing

Outcome Measures

Primary Outcomes (1)

• quick DASH score

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

  6 months

Secondary Outcomes (5)

• The presence of nail deformity.

  6 months

• Pulp volume compared to the contralateral finger: on lateral X-ray

  6 months

• presence of painful neuroma

  6 months

• Sensory related outcome in the form of Two point discrimination test (Weber index)

  6 months

• Finger length: expressed as a shortage in mm. compared to contralateral finger.

  6 months

Study Arms (2)

Flaps Coverage

EXPERIMENTAL

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

Occlusive Dressing

EXPERIMENTAL

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

Interventions

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.

Flaps Coverage

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.

Occlusive Dressing

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• · Old or complicated fingertip injuries.
• Non-exposed bone fingertip injury (Allen type1).
• Patients with severe debilitating disease.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of medicine Assiut University

Asyut, Egypt

Location

MeSH Terms

Conditions

Arm Injuries

Interventions

Occlusive Dressings

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assiut University , resident doctor at orthopedic and trauma department assiut university hospital

Model Details: 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.

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: June 21, 2017
• Study Start: January 1, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: May 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)