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

NCT ID: NCT03193983

Last Updated: 2020-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-05-31

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.

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

Conditions

Injury Arm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Flaps Coverage

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Occlusive Dressing

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Abdelnasser Abdelfatah Farghay

Assiut University , resident doctor at orthopedic and trauma department assiut university hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of medicine Assiut University

Asyut, , Egypt

Countries

Egypt

Other Identifiers

AssiutUMAAFDD

Identifier Type: -

Identifier Source: org_study_id