Operative Treatment vs Treatment With Semi-occlusive Dressing - a Randomized, Controlled Trial on Finger Amputations

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07175675
• Lead Sponsor: Tampere University Hospital

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?

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 Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-08
• Study First Submitted QC: 2025-09-09
• Last Update Submitted: 2025-09-09
• Study Start: 2025-09-10
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16
• Primary Completion: 2040-01-01
• Study Completion: 2040-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 252

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PRWHE	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.

Secondary Outcome Measures

Name	Time	Method
PRWHE 1 month	1 month	PRWHE mean difference (MD) between treatment arms in each stratum with the associated 95% confidence interval (CI) at 1 month post-randomization.
PRWHE 3 months	3 months	PRWHE mean difference (MD) between treatment arms in each stratum with the associated 95% confidence interval (CI) at 3 months post-randomization.
PRWHE 6 months	6 months	PRWHE mean difference (MD) between treatment arms in each stratum with the associated 95% confidence interval (CI) at 6 months post-randomization.
Return to daily activities 1 month	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.
Return to daily activities 3 months	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.
Return to daily activities 6 months	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.
Return to daily activities 12 months	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.
Michigan Hand Questionnaire (MHQ) aesthetics subsection 6 months	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.
Michigan Hand Questionnaire (MHQ) aesthetics subsection 12 months	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.
Cold Intolerance Symptom Severity (CISS) 6 months	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.
Cold Intolerance Symptom Severity (CISS) 12 months	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.
Patient Accepted Symptom State (PASS) 3 months	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
Patient Accepted Symptom State (PASS) 6 months	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
Patient Accepted Symptom State (PASS) 1 month	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
Patient Accepted Symptom State (PASS) 12 months	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
Standard two-point discrimination	12 months	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.
Grip strength	12 months	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.
Moberg pick up test (MPUT)	12 months	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.
Range of motion (ROM)	12 months	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.
Difference in bony length	12 months	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

Trial Locations

Locations (1)

Tampere Univesity Hospital; 🇫🇮 Tampere, Finland