Clinical trial NCT03193983: V-Y Flap Versus Occlusive Dressing in Treating Fingertip Injuries With Exposed Bone
Official title: V-Y Flap Versus Occlusive Dressing in Treating Fingertip Injuries With Exposed Bone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injury Arm
Keywords: occlusive dressing
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-06-21
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: quick DASH score
timeFrame: 6 months
Secondary outcomes:
measure: The presence of nail deformity.
timeFrame: 6 months
measure: Pulp volume compared to the contralateral finger: on lateral X-ray
timeFrame: 6 months
measure: presence of painful neuroma
timeFrame: 6 months
measure: Sensory related outcome in the form of Two point discrimination test (Weber index)
timeFrame: 6 months
measure: Finger length: expressed as a shortage in mm. compared to contralateral finger.
timeFrame: 6 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of medicine Assiut University
Study officials:
References: