Fingertips Traumatic AmputationsFINACTNCT07175675
Operative Treatment vs Treatment With Semi-occlusive Dressing for Single Finger Amputations
A study testing Operative treatment of surgeons choice and Semi-occlusive film in people with Fingertips Traumatic Amputations and Finger Injuries, run by Tampere University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fingertips Traumatic Amputations, Finger Injuries, Finger
- What is being tested?
- Operative treatment of surgeons choice and Semi-occlusive film
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteFinland
- Study dates
- 27 Oct 2025to Jan 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Tampere Univesity Hospital
Tampere, 33200
Reetta M Kvist, Licentiate, reetta.kvist@pirha.fi
Jarkko J Jokihaara, Professor, jarkko.jokihaara@tuni.fi
About this study
Official title: Operative Treatment vs Treatment With Semi-occlusive Dressing - a Randomized, Controlled Trial on Finger Amputations
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?
Read the 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.
- Conditions
- Fingertips Traumatic Amputations, Finger Injuries, Finger, Finger Injury, Amputation, Traumatic, Amputation
- Being tested
- Operative treatment of surgeons choice, Semi-occlusive film
- Keywords
- finger amputation, single finger amputation, single digit amputation
- Medical subject headings
- Finger Injuries, Amputation, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operative treatment of surgeons choiceProcedure or surgery
treatment of single finger amputation with revision amputation, local or micro-vascular flap as best befits each specific injury
Semi-occlusive filmProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Tamai zone 1 operative | Active comparator | operative treatment of surgeons choice Receives: Procedure: Operative treatment of surgeons choice |
| Tamai Zone 1 non-operative | Experimental | treatment with semi-occlusive film Receives: Procedure: Semi-occlusive film |
| Tamai zone 2 operative | Active comparator | Operative treatment of surgeons choice Receives: Procedure: Operative treatment of surgeons choice |
| Tamai Zone 2 non-operative | Experimental | treatment with semi-occlusive film Receives: Procedure: Semi-occlusive film |
| Tamai Zone 3-4 operative (fingers II-V) | Active comparator | Operative treatment of surgeons choice Receives: Procedure: Operative treatment of surgeons choice |
| Tamai Zone 3-4 non-operative (fingers II-V) | Experimental | treatment with semi-occlusive film Receives: Procedure: Semi-occlusive film |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (20)
PRWHE 1 month
PRWHE mean difference (MD) between treatment arms in each stratum with the associated 95% confidence interval (CI) at 1 month post-randomization.
Measured: 1 month
PRWHE 3 months
PRWHE mean difference (MD) between treatment arms in each stratum with the associated 95% confidence interval (CI) at 3 months post-randomization.
Measured: 3 months
PRWHE 6 months
PRWHE mean difference (MD) between treatment arms in each stratum with the associated 95% confidence interval (CI) at 6 months post-randomization.
Measured: 6 months
Return to daily activities 1 month
return to daily activities is collected at 1, 3, 6, and 12 months. Amputation injuries are significant indicators for being off work and having a prolonged time off work. Potential difference between treatment arms in Return to ordinary daily activities could have wider economic implications and work as a factor in determining the most beneficial treatment option for each patient.
Measured: 1 month
Return to daily activities 3 months
return to daily activities is collected at 1, 3, 6, and 12 months. Amputation injuries are significant indicators for being off work and having a prolonged time off work. Potential difference between treatment arms in Return to ordinary daily activities could have wider economic implications and work as a factor in determining the most beneficial treatment option for each patient.
Measured: 3 months
Return to daily activities 6 months
return to daily activities is collected at 1, 3, 6, and 12 months. Amputation injuries are significant indicators for being off work and having a prolonged time off work. Potential difference between treatment arms in Return to ordinary daily activities could have wider economic implications and work as a factor in determining the most beneficial treatment option for each patient.
Measured: 6 months
Return to daily activities 12 months
return to daily activities is collected at 1, 3, 6, and 12 months. Amputation injuries are significant indicators for being off work and having a prolonged time off work. Potential difference between treatment arms in Return to ordinary daily activities could have wider economic implications and work as a factor in determining the most beneficial treatment option for each patient.
Measured: 12 months
Michigan Hand Questionnaire (MHQ) aesthetics subsection 6 months
MHQ aesthetics subsection will be collected at 6 and 12 months. We will analyse a MD between treatment arms in each stratum with the associated 95% CI. Reliability, validity, and responsiveness of the MHQ is well-documented. Aesthetics is of interest to measure patient satisfaction with more than pain or function focused questionnaires.
Measured: 6 months
Michigan Hand Questionnaire (MHQ) aesthetics subsection 12 months
MHQ aesthetics subsection will be collected at 6 and 12 months. We will analyse a MD between treatment arms in each stratum with the associated 95% CI. Reliability, validity, and responsiveness of the MHQ is well-documented. Aesthetics is of interest to measure patient satisfaction with more than pain or function focused questionnaires.
Measured: 12 months
Cold Intolerance Symptom Severity (CISS) 6 months
We will analyse a MD between treatment arms in each stratum with the associated 95% CI. Cold intolerance is recognized as a disabling sequelae of upper extremity trauma, especially when neurovascular structures are involved. CISS test score ranges between a minimum of 4 and a maximum of 100, where lower is better.
Measured: 6 months
Cold Intolerance Symptom Severity (CISS) 12 months
We will analyse a MD between treatment arms in each stratum with the associated 95% CI. Cold intolerance is recognized as a disabling sequelae of upper extremity trauma, especially when neurovascular structures are involved. CISS test score ranges between a minimum of 4 and a maximum of 100, where lower is better.
Measured: 12 months
Patient Accepted Symptom State (PASS) 1 month
PASS is collected at 1, 3, 6 and 12 months. PASS will be assessed with the statement, "I am satisfied with the pain level and function of my finger/thumb," rated on a 5-point Likert scale (strongly disagree, somewhat disagree, neither agree nor disagree, somewhat agree, strongly agree). We will also assess whether the patients would choose the same treatment again with the statement "If I would be in the same circumstances, I would be willing to undergo this treatment again" rated on the same 5-point Likert scale as the previous statement. Results will be dichotomized between 'neither agree nor disagree' and 'somewhat agree' for both statements. This type of questionnaire has been shown to have good test-retest reliability and construct validity
Measured: 1 month
Patient Accepted Symptom State (PASS) 3 months
PASS is collected at 1, 3, 6 and 12 months. PASS will be assessed with the statement, "I am satisfied with the pain level and function of my finger/thumb," rated on a 5-point Likert scale (strongly disagree, somewhat disagree, neither agree nor disagree, somewhat agree, strongly agree). We will also assess whether the patients would choose the same treatment again with the statement "If I would be in the same circumstances, I would be willing to undergo this treatment again" rated on the same 5-point Likert scale as the previous statement. Results will be dichotomized between 'neither agree nor disagree' and 'somewhat agree' for both statements. This type of questionnaire has been shown to have good test-retest reliability and construct validity
Measured: 3 months
Patient Accepted Symptom State (PASS) 6 months
PASS is collected at 1, 3, 6 and 12 months. PASS will be assessed with the statement, "I am satisfied with the pain level and function of my finger/thumb," rated on a 5-point Likert scale (strongly disagree, somewhat disagree, neither agree nor disagree, somewhat agree, strongly agree). We will also assess whether the patients would choose the same treatment again with the statement "If I would be in the same circumstances, I would be willing to undergo this treatment again" rated on the same 5-point Likert scale as the previous statement. Results will be dichotomized between 'neither agree nor disagree' and 'somewhat agree' for both statements. This type of questionnaire has been shown to have good test-retest reliability and construct validity
Measured: 6 months
Patient Accepted Symptom State (PASS) 12 months
PASS is collected at 1, 3, 6 and 12 months. PASS will be assessed with the statement, "I am satisfied with the pain level and function of my finger/thumb," rated on a 5-point Likert scale (strongly disagree, somewhat disagree, neither agree nor disagree, somewhat agree, strongly agree). We will also assess whether the patients would choose the same treatment again with the statement "If I would be in the same circumstances, I would be willing to undergo this treatment again" rated on the same 5-point Likert scale as the previous statement. Results will be dichotomized between 'neither agree nor disagree' and 'somewhat agree' for both statements. This type of questionnaire has been shown to have good test-retest reliability and construct validity
Measured: 12 months
Standard two-point discrimination
Tests evaluating finger pulp sensitivity are frequently used in clinical practice. S2PD has been used in many digital nerve repair studies, and has good test retest and interobserver reliability, although has received criticism for lack of standardization in previous studies. S2PD normative results depend on the age of the patients, being close to 2mm in younger patients and around 4mm in elderly population. Generally, the lower the result, the better sensation is in the fingertip.
Measured: 12 months
Moberg pick up test (MPUT)
MPUT is a standardized test designed to evaluate hand dexterity. Fine motor dexterity of the hand can be affected by disruptions in sensation of fingertips, meriting use of this outcome measure for this study. MPUT normative data depends on the age of the patient and is approximately 12 seconds for young patients (20-39yo) and 16-17 seconds for elderly patients (60+yo). Generally, the lower the result, the better.
Measured: 12 months
Range of motion (ROM)
ROM is measured to reveal whether the remaining joints of the affected digit are regaining mobility or if there are limitations due to scar tissue, contractures, or stiffness. The functional range of motion is 19°-71° at the metacarpophalangeal, 23°-87° at proximal interphalangeal, and 10°-64° at distal interphalangeal joints.
Measured: 12 months
Grip strength
Grip strength is measured using Jamar dynamometer, providing standardized, reliable data for comparisons. The closer the result is to that of the uninjured hand, the better.
Measured: 12 months
Difference in bony length
X-rays are taken from the affected hand at baseline before any interventions and at 12-month follow-up to measure potential changes in bony length of the affected digit between treatment arms of each stratum
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start27 Oct 2025
- Primary completionJan 2032 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fingertips Traumatic AmputationsStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jarkko Jokihaara, Professor, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175675
- Sponsor's protocol ID
- R25023
- Acronym
- FINACT
- Status last verified
- Nov 2025
- First submitted
- 8 Sep 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operative Treatment vs Treatment With Semi-occlusive Dressing - a Randomized, Controlled Trial on Finger Amputations
- ClinicalTrials.gov ID
- NCT07175675
- Acronym / sponsor ID
- FINACT / R25023
- Conditions
- Fingertips Traumatic Amputations, Finger Injuries, Finger, Finger Injury, Amputation, Traumatic, Amputation
- Keywords
- finger amputation, single finger amputation, single digit amputation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- Jan 2032 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Tamai zone 1 operative | Active comparator | Procedure: Operative treatment of surgeons choiceoperative treatment of surgeons choice |
| Tamai Zone 1 non-operative | Experimental | Procedure: Semi-occlusive filmtreatment with semi-occlusive film |
| Tamai zone 2 operative | Active comparator | Procedure: Operative treatment of surgeons choiceOperative treatment of surgeons choice |
| Tamai Zone 2 non-operative | Experimental | Procedure: Semi-occlusive filmtreatment with semi-occlusive film |
| Tamai Zone 3-4 operative (fingers II-V) | Active comparator | Procedure: Operative treatment of surgeons choiceOperative treatment of surgeons choice |
| Tamai Zone 3-4 non-operative (fingers II-V) | Experimental | Procedure: Semi-occlusive filmtreatment with semi-occlusive film |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Operative treatment of surgeons choicetreatment of single finger amputation with revision amputation, local or micro-vascular flap as best befits each specific injury | Procedure or surgery | Tamai Zone 3-4 operative (fingers II-V), Tamai zone 1 operative, Tamai zone 2 operative |
| Semi-occlusive filmThe 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. | Procedure or surgery | Tamai Zone 1 non-operative, Tamai Zone 2 non-operative, Tamai Zone 3-4 non-operative (fingers II-V) |
Primary outcome
PRWHE
Time frame: 12 months
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.
20 secondary outcomes
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
Patient Accepted Symptom State (PASS) 3 months
Time frame: 3 months
Patient Accepted Symptom State (PASS) 6 months
Time frame: 6 months
Patient Accepted Symptom State (PASS) 12 months
Time frame: 12 months
Standard two-point discrimination
Time frame: 12 months
Moberg pick up test (MPUT)
Time frame: 12 months
Range of motion (ROM)
Time frame: 12 months
Grip strength
Time frame: 12 months
Difference in bony length
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jarkko Jokihaara, Professor principal investigator
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operative treatment of surgeons choice and Semi-occlusive film in people with Fingertips Traumatic Amputations and Finger Injuries, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reetta M Kvist, Licentiate (+358 03311611, reetta.kvist@pirha.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PRWHE (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.