Occlusive Dressing vs Palmar Pedicular Island Flap in Fingertip Amputation

Not Applicable

• Conditions: Finger Injuries
• Interventions: Other: occlusive dressing; Procedure: coverage of the fingertips with bipedicled palmar island flap

• Registration Number: NCT04631081
• Lead Sponsor: Centre de la main - CHUV

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.

Study Timeline

• Study First Submitted: 2020-11-10
• Study First Submitted QC: 2020-11-16
• Study First Posted: 2020-11-17
• Study Start: 2021-07-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-08
• Last Update Posted: 2021-09-16
• Primary Completion: 2022-07-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Occlusive dressing group	occlusive dressing	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
Surgical group	coverage of the fingertips with bipedicled palmar island flap	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.

Primary Outcome Measures

Name	Time	Method
Patient's satisfaction assessment according to the therapeutic option (occlusive dressing vs flap).	Enrollment in the study for one year	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.

Secondary Outcome Measures

Name	Time	Method
Objective evaluation of fingertips	Enrollment in the study for one year	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.

Trial Locations

Locations (2)

Hôpital du Valais; 🇨🇭 Sierre, Valais, Switzerland

HUG; 🇨🇭 Genève, Switzerland