Operative Treatment vs Treatment With Semi-occlusive Dressing for Single Finger Amputations
FINACT
1 other identifier
interventional
252
1 country
1
Brief Summary
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2025
CompletedFirst Posted
Study publicly available on registry
September 16, 2025
CompletedStudy Start
First participant enrolled
October 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2032
November 21, 2025
November 1, 2025
6.2 years
September 8, 2025
November 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PRWHE
Our primary outcome measure is PRWHE mean difference (MD) between treatment arms in each stratum with the associated 95% confidence interval (CI) at 12 months post-randomization. Patient-Reported Wrist and Hand Evaluation (PRWHE) was chosen, because it covers both pain and loss of function which are the main symptoms after a digital amputation, has evidence of reliability, validity and responsiveness in hand and wrist trauma population, and is considered slightly more responsive than DASH. As a patient reported outcome, it is prone to ascertainment bias - especially since in this study setting it is not possible to blind the participant to given treatment. To overcome this, we have included several objective outcome measures as secondary outcomes. Nevertheless, Patient-Reported Outcome Measures are considered the most meaningful instruments for outcome evaluation in musculoskeletal conditions, because those assess patient-perceived important symptoms and disability.
12 months
Secondary Outcomes (20)
PRWHE 1 month
1 month
PRWHE 3 months
3 months
PRWHE 6 months
6 months
Return to daily activities 1 month
1 month
Return to daily activities 3 months
3 months
- +15 more secondary outcomes
Study Arms (6)
Tamai zone 1 operative
ACTIVE COMPARATORoperative treatment of surgeons choice
Tamai Zone 1 non-operative
EXPERIMENTALtreatment with semi-occlusive film
Tamai zone 2 operative
ACTIVE COMPARATOROperative treatment of surgeons choice
Tamai Zone 2 non-operative
EXPERIMENTALtreatment with semi-occlusive film
Tamai Zone 3-4 operative (fingers II-V)
ACTIVE COMPARATOROperative treatment of surgeons choice
Tamai Zone 3-4 non-operative (fingers II-V)
EXPERIMENTALtreatment with semi-occlusive film
Interventions
treatment of single finger amputation with revision amputation, local or micro-vascular flap as best befits each specific injury
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tampere Univesity Hospital
Tampere, 33200, Finland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jarkko Jokihaara, Professor
Tampere University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2025
First Posted
September 16, 2025
Study Start
October 27, 2025
Primary Completion (Estimated)
January 1, 2032
Study Completion (Estimated)
January 1, 2032
Last Updated
November 21, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Study protocol will be published in an appropriate journal and it and ICF and SAP will be available from the publication date onward. Other IPD as described above will be available after the completion of the study.
- Access Criteria
- Summary statistics may be shared outside the study group if reasonable request is received - for example, for meta analysis purposes.
Individual participant data is going to be analysed in pseudonymised form. Data can be shared outside the study group but within the EU and EEA area for this study's statistical analysis purpose only. The Data Safety Monitoring Committee has the right to review the data collected in the study and check that the study has been carried out in an appropriate manner. Individual participants cannot be recognized from the published results. The results are going to be published in peer-reviewed international medical journals. Summary statistics may be shared outside the study group if reasonable request is received - for example, for meta analysis purposes. No Identifying data will be shared outside the study group for any reason.