Operative Treatment vs Treatment With Semi-occlusive Dressing for Single Finger Amputations
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Operative treatment of surgeons choice, Semi-occlusive film.
- Who it may be relevant to
- Registry conditions: Fingertips Traumatic Amputations, Finger Injuries, Finger, Finger Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Operative Treatment vs Treatment With Semi-occlusive Dressing - a Randomized, Controlled Trial on Finger Amputations
Overview
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
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.
Interventions
- Procedure Operative treatment of surgeons choice
treatment of single finger amputation with revision amputation, local or micro-vascular flap as best befits each specific injury - 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.
Primary outcome measures
- PRWHE [Time frame: 12 months]
Secondary outcome measures (12)
- PRWHE 1 month [Time frame: 1 month]
- PRWHE 3 months [Time frame: 3 months]
- PRWHE 6 months [Time frame: 6 months]
- Return to daily activities 1 month [Time frame: 1 month]
- Return to daily activities 3 months [Time frame: 3 months]
- Return to daily activities 6 months [Time frame: 6 months]
- Return to daily activities 12 months [Time frame: 12 months]
- Michigan Hand Questionnaire (MHQ) aesthetics subsection 6 months [Time frame: 6 months]
- Michigan Hand Questionnaire (MHQ) aesthetics subsection 12 months [Time frame: 12 months]
- Cold Intolerance Symptom Severity (CISS) 6 months [Time frame: 6 months]
- Cold Intolerance Symptom Severity (CISS) 12 months [Time frame: 12 months]
- Patient Accepted Symptom State (PASS) 1 month [Time frame: 1 month]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Finland · 1 center
- Tampere Univesity Hospital — Tampere
Identifiers
NCT: NCT07175675 · R25023