Skip to content

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04631081
Enrollment
100
Registered
2020-11-17
Start date
2021-07-01
Completion date
2023-07-01
Last updated
2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Finger Injuries

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.

Interventions

PROCEDUREcoverage 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.

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.

Sponsors

Centre de la main - CHUV
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

open-label, randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Patient's satisfaction assessment according to the therapeutic option (occlusive dressing vs flap).Enrollment in the study for one yearPatients 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

MeasureTime frameDescription
Objective evaluation of fingertipsEnrollment in the study for one yearDistal 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.

Countries

Switzerland

Contacts

Primary ContactSébastien Durand, MD, PhD
sebastien.durand@chuv.ch795567893
Backup ContactLeslie Elahi
leslie.rausis@chuv.ch795560189

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026