Operative Treatment vs Treatment With Semi-occlusive Dressing - a Randomized, Controlled Trial on Finger Amputations
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Tampere University Hospital
- Enrollment
- 252
- Locations
- 1
- Primary Endpoint
- PRWHE
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Tamai zone 1 operative
operative treatment of surgeons choice
Intervention: Operative treatment of surgeons choice (Procedure)
Tamai Zone 1 non-operative
treatment with semi-occlusive film
Intervention: Semi-occlusive film (Procedure)
Tamai zone 2 operative
Operative treatment of surgeons choice
Intervention: Operative treatment of surgeons choice (Procedure)
Tamai Zone 2 non-operative
treatment with semi-occlusive film
Intervention: Semi-occlusive film (Procedure)
Tamai Zone 3-4 operative (fingers II-V)
Operative treatment of surgeons choice
Intervention: Operative treatment of surgeons choice (Procedure)
Tamai Zone 3-4 non-operative (fingers II-V)
treatment with semi-occlusive film
Intervention: Semi-occlusive film (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
- Return to daily activities 6 months(6 months)
- Return to daily activities 12 months(12 months)
- Michigan Hand Questionnaire (MHQ) aesthetics subsection 6 months(6 months)
- Michigan Hand Questionnaire (MHQ) aesthetics subsection 12 months(12 months)
- Cold Intolerance Symptom Severity (CISS) 6 months(6 months)
- Cold Intolerance Symptom Severity (CISS) 12 months(12 months)
- Patient Accepted Symptom State (PASS) 3 months(3 months)
- Patient Accepted Symptom State (PASS) 6 months(6 months)
- Patient Accepted Symptom State (PASS) 1 month(1 month)
- Patient Accepted Symptom State (PASS) 12 months(12 months)
- Standard two-point discrimination(12 months)
- Grip strength(12 months)
- Moberg pick up test (MPUT)(12 months)
- Range of motion (ROM)(12 months)
- Difference in bony length(12 months)