Occlusive Dressing vs Palmar Pedicular Island Flap in Fingertip Amputation

Last updated: September 8, 2021
Sponsor: Centre de la main - CHUV
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04631081
2020-01356
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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.

Study Design

Total Participants: 100
Study Start date:
July 01, 2021
Estimated Completion Date:
July 01, 2023

Study 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.

Connect with a study center

  • Hôpital du Valais

    Sierre, Valais 3960
    Switzerland

    Active - Recruiting

  • HUG

    Genève, 1205
    Switzerland

    Active - Recruiting

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