Operative Treatment vs Treatment With Semi-occlusive Dressing for Single Finger Amputations (FINACT)

Tampere University Hospital

Status: Enrolling

Conditions: Finger Injuries; Amputation, Traumatic; Fingertips Traumatic Amputations; Finger Injury; Amputation; Finger

Treatments: Procedure: Semi-occlusive film; Procedure: Operative treatment of surgeons choice

Study type: Interventional

Funder types: Other

Identifiers

NCT07175675

R25023

Details and patient eligibility

About

The goal of this interventional study is to find out whether conservative treatment with semi-occlusive film is superior to surgical treatment in single finger amputations in adult population. The main question it aims to answer is:

Is PRWHE (Patient Reported Wrist and Hand Evaluation) total score measured at 12 months after injury better in conservatively or operatively treated patients?

Full description

The aim of this study is to compare the outcomes of operative treatment (chosen by the surgeon, including amputation revision with primary skin closure or flap coverage for the tissue defect) versus non-operative treatment using a semi-occlusive dressing for single finger amputations. This study is a randomized controlled superiority trial including three strata, each with two treatment arms, allocated in a 1:1 ratio. The three strata of the study design are based on the level of amputation as follows: Stratum 1 = Tamai Zone 1, Stratum 2 = Tamai Zone 2, Stratum 3 = Tamai Zones 3+4 (fingers II-V only). In all strata, the treatment arms are A (operative) and B (non-operative). Randomization will be performed as computer generated randomization with 1:1 allocation.

Primary objective is to determine whether treatment with semi-occlusive dressings is superior to operative treatment after a single finger amputation in each stratum, measured with PRWHE at 12 months after injury.

Enrollment: 252 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age >18, single digit injury, Amputation at Tamai zones 1+2 in all digits or Tamai zones 3+4 in digits II-V, Able to understand Finnish and to complete self-reported questionnaires

Exclusion criteria

• Previous partial or total amputation of the injured digit, Previous condition which affects significantly the function and/or symptoms of the affected hand, Patient is pregnant at the time of recruitment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

252 participants in 6 patient groups

Tamai zone 1 operative

Active Comparator group

Description:

operative treatment of surgeons choice

Treatment:

Procedure: Operative treatment of surgeons choice

Tamai Zone 1 non-operative

Experimental group

Description:

treatment with semi-occlusive film

Treatment:

Procedure: Semi-occlusive film

Tamai zone 2 operative

Active Comparator group

Description:

Operative treatment of surgeons choice

Treatment:

Procedure: Operative treatment of surgeons choice

Tamai Zone 2 non-operative

Experimental group

Description:

treatment with semi-occlusive film

Treatment:

Procedure: Semi-occlusive film

Tamai Zone 3-4 operative (fingers II-V)

Active Comparator group

Description:

Operative treatment of surgeons choice

Treatment:

Procedure: Operative treatment of surgeons choice

Tamai Zone 3-4 non-operative (fingers II-V)

Experimental group

Description:

treatment with semi-occlusive film

Treatment:

Procedure: Semi-occlusive film