Occlusive Dressing vs Palmar Pedicular Island Flap in Fingertip Amputation

Finger Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04631081
• Other study ID #: 2020-01356
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: September 2021
• Source: Centre de la main - CHUV
• Contact: Sébastien Durand, MD, PhD
• Phone: 795567893
• Email: sebastien.durand[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Finger Injuries

Intervention

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.

Locations

Country	Name	City	State
Switzerland	HUG	Genève
Switzerland	Hôpital du Valais	Sierre	Valais

Sponsors (1)

Lead Sponsor	Collaborator
Centre de la main - CHUV

Country where clinical trial is conducted

Switzerland, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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