A Prospective Randomized Study to Evaluate Sensory Recovery of Digital Nerves After Primary Repair Performed by Microsurgical Epineural End-to-end Neurorrhaphy Alone, or in Combination With an Enwrapping With Fibrin Sealant Tisseel®
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- two point discrimination
研究概览
简要总结
Evaluation of sensitivity after primary surgical treatment of digital nerve injuries with microsurgical epineural end-to-end neurorrhaphy alone or in combination with the fibrin glue Tisseel®
详细描述
Lacerations of the fingers with nerve injuries are a common reason for a presentation at the surgical emergency ward of the Inselspital Bern. The patient complains of either reduced sensitivity or even complete numbness in the affected finger. This leads to a clear functional loss in daily activities and should be reliably tested during the clinical examination. If a nerve lesion is suspected, the wound and the affected nerve should be explored in the operating room. If the suspicion is confirmed, the sheath of the two nerve endings can be sewn under the microscope or with surgical loupes.
Tension free microsurgical epineural end-to-end neurorrhaphy of digital nerves after sharp or blunt lesions is a simple and effective procedure in order to regain sensory recovery and prevent neuroma formation.
Industry is promoting different aids in order to achieve better outcomes after repair - such as tissue glue, grafts and conduits. These products are more or less expensive, which becomes more and more important as the general cost in the Swiss health system are progressively increasing.
The aim of this randomized, prospective controlled study is thus to compare the clinical benefit of a primary epineural end-to-end neurorrhaphy combined with fibrin glue (Tisseel®) versus a simple epineural end-to-end neurorrhaphy alone.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The study is examiner- and patient blinded. While the operating surgeon is not blinded, postoperative examinations will be performed by physicians who do not know the group assignment of the patient.
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
- •Written consent to participate in the study
- •Acute digital nerve lesion(s) distal to the superficial arterial arch on one or more fingers that qualify for primary direct end-to-end microsurgical epineural neurorrhaphy
- •Age ≥18 years
排除标准
- •Lesions that do not allow a tension-free direct suture, partial transections, amputation, re-vascularisation
- •Age < 18 years
- •Pre-operation on the injured finger
- •Clinical comparison with contralateral finger not possible (e.g. due to amputation).
- •Treatment that is known to inhibit the growth/regeneration of nerves impaired or can cause neuropathy - such as chemo- or radiotherapy before or during the whole study
- •Systemic and local neurological impairments (polyneuropathy, diabetes mellitus, carpal tunnel syndrome, etc.)
- •History of vascular diseases like Raynaud's disease syndrome that affects blood flow or sensation in the upper can affect the extremities
- •Known or suspected non-compliance
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, or dementia
- •Women who are pregnant (urin pregnancy test) or breast feeding. Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
- •Previous enrolment into the current study
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
- •Contraindications to the investigational product, e.g. known allergy to components of the Tisseel® fibrin glue
- •Participation in another interventional study within the 30 days preceding and during the present study
研究组 & 干预措施
Microsurgical end-to-end neurorrhaphy in combination with an enwrapping with fibrin sealant Tisseel®
This group of patients receives a simple, tension-free, end-to-end microsurgical neurorrhaphy in combination with an enwrapping with fibrin sealant Tisseel®.
干预措施: Tisseel® (Drug)
结局指标
主要结局
two point discrimination
时间窗: 24 weeks postoperative
For this purpose a standardized two-point-discriminator (PADGETT DeMayo Two-Point Discrimination Device, Used for Post hand surgery diagnostic. MFID: PM-855) is used
次要结局
- Neuroma formation(48 weeks postoperative)
- Grip strength(48 weeks postoperative)
- Active range of motion(48 weeks postoperative)
- Pain with the Numeric Rating Scale (NRS): 0 indicating no and 10 indicating maximum pain(48 weeks postoperative)
- quickDASH score (Disabilities of the Shoulder, Arm and Hand)(48 weeks postoperative)
- STI-Test: (Shape-Texture Identification test)(48 weeks postoperative)