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

NCT ID: NCT07175675

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-27

Study Completion Date

2032-01-31

Brief Summary

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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?

Detailed Description

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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.

Conditions

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Fingertips Traumatic Amputations Finger Injuries Finger Finger Injury Amputation, Traumatic Amputation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Tamai zone 1 operative

operative treatment of surgeons choice

Group Type ACTIVE_COMPARATOR

Operative treatment of surgeons choice

Intervention Type PROCEDURE

treatment of single finger amputation with revision amputation, local or micro-vascular flap as best befits each specific injury

Tamai Zone 1 non-operative

treatment with semi-occlusive film

Group Type EXPERIMENTAL

Semi-occlusive film

Intervention Type PROCEDURE

The film is placed on a cleansed wound surface. bone is shortened to the level of injury. Visible nerves, arteries and tendons are cut and allowed to retract. The film is to be changed once weekly until the wound has closed.

Tamai zone 2 operative

Operative treatment of surgeons choice

Group Type ACTIVE_COMPARATOR

Operative treatment of surgeons choice

Intervention Type PROCEDURE

treatment of single finger amputation with revision amputation, local or micro-vascular flap as best befits each specific injury

Tamai Zone 2 non-operative

treatment with semi-occlusive film

Group Type EXPERIMENTAL

Semi-occlusive film

Intervention Type PROCEDURE

The film is placed on a cleansed wound surface. bone is shortened to the level of injury. Visible nerves, arteries and tendons are cut and allowed to retract. The film is to be changed once weekly until the wound has closed.

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

Operative treatment of surgeons choice

Group Type ACTIVE_COMPARATOR

Operative treatment of surgeons choice

Intervention Type PROCEDURE

treatment of single finger amputation with revision amputation, local or micro-vascular flap as best befits each specific injury

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

treatment with semi-occlusive film

Group Type EXPERIMENTAL

Semi-occlusive film

Intervention Type PROCEDURE

The film is placed on a cleansed wound surface. bone is shortened to the level of injury. Visible nerves, arteries and tendons are cut and allowed to retract. The film is to be changed once weekly until the wound has closed.

Interventions

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Operative treatment of surgeons choice

treatment of single finger amputation with revision amputation, local or micro-vascular flap as best befits each specific injury

Intervention Type PROCEDURE

Semi-occlusive film

The film is placed on a cleansed wound surface. bone is shortened to the level of injury. Visible nerves, arteries and tendons are cut and allowed to retract. The film is to be changed once weekly until the wound has closed.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jarkko Jokihaara, Professor

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

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Tampere Univesity Hospital

Tampere, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Reetta M Kvist, Licentiate

Role: CONTACT

+358 03311611

Jarkko J Jokihaara, Professor

Role: CONTACT

+35803311611

Facility Contacts

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Reetta M Kvist, Licentiate

Role: primary

Jarkko J Jokihaara, Professor

Role: backup

Other Identifiers

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R25023

Identifier Type: -

Identifier Source: org_study_id

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