Skin Involvement in Dupuytren Surgical Treatment Outcome: Interventional Study on Prognostic Value of Cutometry, Ultrasound and Histopathology
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Total Passive Extension Deficit (TPED) 3 months post-operative
研究概览
简要总结
Palmar skin is often retracted in Dupuytren disease (DD), making surgical management challenging and skin-preserving surgery difficult. Based on clinical experience in DD surgery and outcome, it is suspected that recurrence may be associated with such retracted skin. Possibly, this is due to presence and persistence of aligned myofibroblasts (MF), fixed to the deepest dermal layers. This interventional study aims to investigate the pathophysiological involvement of palmar skin in Dupuytren disease, and its implications for prognostics and treatment.
详细描述
Dupuytren disease (DD) is a common hand disorder, in which a spontaneous fibro-proliferative process (fibrosis) forms strands and nodules in the fascia palmaris of the hand. Normal fibroblasts develop into nodules of myofibroblasts (MF), forming collagen strands which retract skin and cause painless, yet disabling finger contractures. Although numerous conservative treatment options are being explored for these invalidating contractures, surgical removal of DD strands and nodules (through microfasciectomy) remains the standard of care. Retracted skin often makes surgical management challenging and skin-preserving surgery difficult, some patients even requiring full thickness skin grafting (FTG). The disease is very persistent, with reports of recurrent contractures of over 70%. However, in DD patients undergoing FTG less disease recurrence is noticed. This raises a question about pathophysiological skin involvement and its prognostic and therapeutic implications.
The aim of this prospective, interventional study is to further increase insights in the microscopic role of the skin in DD. In earlier research, retracted skin was associated with myofibroblasts (MF) attached to the deepest skin layers. DD recurrence may thus be associated with such retracted skin, possibly due to presence and persistence of aligned MF, fixed to the deepest dermal layers (finding based on own research). Therefore, this study evaluates MF relation to overlying skin and its impact on clinical outcome of microfasciectomy.
In addition, a pilot study has demonstrated that retracted palmar skin in DD loses elasticity, which can be measured by suction cutometry. Based on these findings, the aim is to assess a potential prognostic value of palmar skin involvement in DD and a possible impact on surgery outcome, by simple suction cutometry.
Third, secure measurement of nodule evolution is a clinical challenge. Ultrasound (US) and MRI scanning have been performed. If observed, nodules are often measured by clinical yardstick assessment. However, this technique is unvalidated and unreliable with inevitable significant inter and intra observer unreliability, which improves with sonography. Therefore, simple ultrasound by the treating clinician provides a good tool to collect data. The V Scan is a user-friendly tool to achieve this and with this study the aim is to introduce this non-invasive scan method to provide a prospective investigation of a measurable prognostic value on surgical treatment outcome in DD, focussing on skin involvement by measuring the distance of the nodule/strand to the skin surface.
Integrating all findings of this interventional study will further increase insights in DD pathophysiology, prognostics, and treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
- •Patients ≥ 18 years old, diagnosed with primary Dupuytren disease.
- •Patients must be scheduled for microfasciectomy.
排除标准
- •Earlier Dupuytren surgery in the hand scheduled for microfasciectomy
- •Patient's unable to give a written participating consent.
- •Younger than 18 years of age.
研究组 & 干预措施
Patients with Dupuytren disease
50 patients scheduled for microfasciectomy will be enrolled.
干预措施: Suction cutometry (Diagnostic Test)
Patients with Dupuytren disease
50 patients scheduled for microfasciectomy will be enrolled.
干预措施: Ultrasound measurement (Diagnostic Test)
Patients with Dupuytren disease
50 patients scheduled for microfasciectomy will be enrolled.
干预措施: Microbiopsy for histological analysis (Procedure)
结局指标
主要结局
Total Passive Extension Deficit (TPED) 3 months post-operative
时间窗: From Baseline to 3 months post-operative
The Extension capability at 3 months post-microfasciectomy. Extension deficit is measured with a goniometer, shown in degrees (°)
次要结局
- Total Passive Extension Deficit (TPED) 12 months post-operative(From Baseline to 12 months post-operative)
- Clinical recurrence(At 1 moment during study (12 months post-operation))
- Distal Pulpa Palmar Crease Distance (DPPCD) at 3 and 12 months(From Baseline to 3 months post-operative and 12 months post-operative)
- Visual Analogue Scale (VAS) pain(3 times during study (pre-operative, 3 months and 12 months post-operative))
- Visual Analogue Scale (VAS) satisfaction(3 times during study (pre-operative, 3 months and 12 months post-operative))
- Brief Michigan Hand Questionnaire(3 times during study (pre-operative, 3 months and 12 months post-operative))
- Rheumatological Unit for Hand Disorders (URAM) scale(3 times during study (pre-operative, 3 months and 12 months post-operative))