NCT04631081

Occlusive Dressing vs Palmar Pedicular Island Flap in Fingertip Amputation

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Centre de la main - CHUV · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Finger Injuries

Interventions

Type	Name	Description
PROCEDURE	coverage of the fingertips with bipedicled palmar island flap	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.
OTHER	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. 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.

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-07-01
• Completion: 2023-07-01
• First posted: 2020-11-17
• Last updated: 2021-09-16

Locations

2 sites across 1 country: Switzerland