Occlusive Dressing vs Palmar Pedicular Island Flap in Fingertip Amputation

Centre de la main - CHUV

Status: Unknown

Conditions: Finger Injuries

Treatments: Other: occlusive dressing; Procedure: coverage of the fingertips with bipedicled palmar island flap

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT04631081

2020-01356

Details and patient eligibility

About

Our study aims to prospectively compare outcomes of conservative treatment (occlusive dressing) to surgery with a palmar bipedicled island flap (modified Tranquilli-Leali flap) in the management of Allen zones II-III-IV fingertip injuries in long fingers. Based on these results, the investigators intend to help provide guidelines to optimize the management, and eventually the satisfaction of these patients.

Full description

The investigators intend to conduct a prospective tricentric (Hand Surgery Service in CHUV( Centre Hospitalier Universitaire Vaudois, Lausanne/ Hand Surgery Service in HUG (Hôpitaux Universitaire de Genève and Hand Surgery Service in Valais hospital, Sierre), open-label, randomized controlled trial: Occlusive dressing versus surgery in fingertips amputation.

The investigators will collect demographic data and informations about the injury including age, sex, medical history and daily medications, occupation, dominant hand, active smoking, mechanism of injury, associated injuries, time from injury to management, size and geometry (volar/transverse/dorsal) of defect, level of amputation (Allen classification), injury and repair of the nail bed.

Patients will be randomized into the occlusive dressing group or the surgical group on their first visit to the Hand Surgery department.

Both groups will have 6 months and 1-year follow-up appointment, including Ultrasound evaluation.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients > 18 years old
• Allen zones II-III-IV long finger amputation.
• Trauma < 48h.

Exclusion criteria

• Patients who are not able to give consent
• Injuries involving the DIP joint, extensor apparatus or requiring osteosynthesis.
• Chronic dermatological disorders of the hand, immunosuppressive drugs or chemotherapy. - Patient without a consent form would be excluded.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Occlusive dressing group

Active Comparator group

Description:

patients will be evaluated on admission and benefit from wound irrigation, debridement and placement of a simple dressing with Adaptic or Jelonet, either in the Emergency department or in the Hand Surgery department. At 48 hours, they will be addressed to the Hand Surgery department to place a self-adhesive polyurethane film according. Follow-up will include a visit at 1 week for dressing change, and then weekly for further dressing change until healing

Treatment:

Other: occlusive dressing

Surgical group

Active Comparator group

Description:

In surgical group, coverage with a bipedicled palmar island flap will be performed ambulatory, either on admission if patients are directly oriented to the Hand Surgery department, or within 48h of initial visit for patients addressed from the Emergency department. The flap group will be evaluated on admission, at 48h, and 6 weeks.

Treatment:

Procedure: coverage of the fingertips with bipedicled palmar island flap