Occlusive Dressing vs Palmar Pedicular Island Flap in Fingertip Amputation

NCT04631081 | Unknown DMC

• 1 other identifier: 2020-01356
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Finger Injuries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Objective evaluation of fingertips

  Enrollment in the study for one year

Study Arms (2)

Occlusive dressing group

ACTIVE COMPARATOR

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

Surgical group

ACTIVE COMPARATOR

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

Interventions

coverage of the fingertips with bipedicled palmar island flap PROCEDURE

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.

Surgical group

occlusive dressing OTHER

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.

Occlusive dressing group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre de la main - CHUV: lead

Study Sites (2)

Hôpital du Valais

Sierre, Valais, 3960, Switzerland

RECRUITING

HUG

Geneva, 1205, Switzerland

RECRUITING

Related Publications (29)

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MeSH Terms

Conditions

Finger Injuries

Interventions

Occlusive Dressings

Condition Hierarchy (Ancestors)

Hand Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies

Study Officials

• Sebastien Durand, MD,PhD

  Service de chirurgie plastique et de la main - CHUV

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sébastien Durand, MD, PhD

CONTACT

795567893; sebastien.durand@chuv.ch

Leslie Elahi

CONTACT

795560189; leslie.rausis@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: open-label, randomized controlled trial

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 17, 2020
• Study Start: July 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2023
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)