Occlusive Dressing vs Palmar Pedicular Island Flap in Fingertip Amputation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Finger Injuries

Intervention / Treatment
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* Procedure: coverage of the fingertips with bipedicled palmar island flap
* Other: occlusive dressing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: open-label, randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Occlusive dressing group<br>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 | Other: occlusive dressing<br>* 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. Follow-up will include a visit at 1 week for dressing change, and then weekly for further dressing change until healing. Skin proximal to the injury will be degreased to increase adherence of the dressing. Distally, the film leaves a pocket to collect wound exudate. During treatment, the foul-smelling liquid produced by the wound and clots collected in the occlusive dressing will not be removed. A gauze covers the occlusive dressing to protect the liquid pocket and cover potential smell.<br>|
| Active Comparator: Surgical group<br>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. | Procedure: coverage of the fingertips with bipedicled palmar island flap<br>* The initial step is wound debridement. To design the flap, a longitudinal line is drawn at the junction of the volar and dorsal parts of the finger, starting from the distal part of the proximal interphalangeal joint flexion crease. It will be harvested from distal to proximal dissecting the digital canal plane. By releasing the Cleland and Grayson ligaments, the neurovascular bundle will be dissected. On the intermediate phalange, the dorsal branch of the neurovascular bundle must be preserved to maintain blood flow to the dorsal skin. Dissection is completed at the junction between the palmo-dorsal arteries and the collateral neurovascular bundles on both sides of the finger. A triangle may be resected at the distal edge of the flap to reshape of the pulp. Bone may be resected if needed to allow tension-free closure of the distal part of the flap. No Immobilization will be necessary.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's satisfaction assessment according to the therapeutic option (occlusive dressing vs flap). | Patients will be instructed to rate their satisfaction (according to different criteria: overall hand function, activities of daily living, work performance, pain, and cosmetic) by checking on a horizontal line their degree of satisfaction. After evaluation, their measurement was considered as a continuous measure (0-100 mm). Higher scores indicate better satisfaction. | Enrollment in the study for one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective evaluation of fingertips | Distal fingertip sensibility (Semmens-Weinstein and 2 points discrimination test). Finger range of motion of the PIP(Proximal InterPhalangeal) and DIP (Distal InterPhalangeal) joints (goniometer) Coloration and pigmentation of the pulp (Dermacatch). Dexterity (Nine hole peg test). Cold intolerance using the Cold Intolerance Symptom Severity (CISS) (40). Hook nail deformity. Distal phalanx bone length before and after treatment (X-Ray). Echography multiparameters analysis: thickness of the pulp (B-mode), vascularization of the pulp (Echo-doppler), Elasticity of the pulp (Shear wave elastography) (25). Complications: infection rate, wound dehiscence rate, flap failure rate. Time of complete healing, time before returning to work. | Enrollment in the study for one year |