Operative Treatment vs Treatment With Semi-occlusive Dressing - a Randomized, Controlled Trial on Finger Amputations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- PRWHE
研究概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Tamai zone 1 operative
operative treatment of surgeons choice
干预措施: Operative treatment of surgeons choice (Procedure)
Tamai Zone 1 non-operative
treatment with semi-occlusive film
干预措施: Semi-occlusive film (Procedure)
Tamai zone 2 operative
Operative treatment of surgeons choice
干预措施: Operative treatment of surgeons choice (Procedure)
Tamai Zone 2 non-operative
treatment with semi-occlusive film
干预措施: Semi-occlusive film (Procedure)
Tamai Zone 3-4 operative (fingers II-V)
Operative treatment of surgeons choice
干预措施: Operative treatment of surgeons choice (Procedure)
Tamai Zone 3-4 non-operative (fingers II-V)
treatment with semi-occlusive film
干预措施: Semi-occlusive film (Procedure)
结局指标
主要结局
PRWHE
时间窗: 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.
次要结局
- 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)