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ClinicalTrials.gov ID

NCT04631081

Lead Sponsor

Centre de la main - CHUVNETWORK

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

100Estimated

Last Update Posted

Sep 16, 2021Actual

Start Date

Jul 1, 2021Actual

Primary Completion Date

Jul 1, 2022Estimated

Completion Date

Jul 1, 2023Estimated

Official Title

Occlusive Dressing vs Palmar Pedicular Island Flap in Fingertip Amputation: A Randomized Controlled Trial

Brief Summary

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.

Detailed 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.

• Finger Injuries

• coverage of the fingertips with bipedicled palmar island flap
• occlusive dressing

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

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.

Primary Purpose

Supportive Care

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Centre de la main - CHUVNETWORK

cindy.bouvet@hug.ch