Clinical trial NCT04631081: Occlusive Dressing vs Palmar Pedicular Island Flap in Fingertip Amputation
Official title: Occlusive Dressing vs Palmar Pedicular Island Flap in Fingertip Amputation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Finger Injuries
Lead sponsor: Centre de la main - CHUV
Sponsor class: NETWORK
First posted: 2020-11-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open-label, randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

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 outcomes:
measure: Patient's satisfaction assessment according to the therapeutic option (occlusive dressing vs flap).
timeFrame: Enrollment in the study for one year
Secondary outcomes:
measure: Objective evaluation of fingertips
timeFrame: Enrollment in the study for one year
Other outcomes:
Locations:
city: Sierre
country: Switzerland
facility: Hôpital du Valais
state: Valais
city: Genève
country: Switzerland
facility: HUG
Study officials:
affiliation: Service de chirurgie plastique et de la main - CHUV
name: Sebastien Durand, MD,PhD
role: PRINCIPAL_INVESTIGATOR
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