Neurological Outcomes Following Carpal Tunnel Decompression: a Comparison of Tissue Adhesive Material and Suture as Wound-closure Techniques
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- median nerve sensory values measured electromyographic (EMG)
研究概览
简要总结
single-centre randomised prospective trial will conducted at the University Hospital of Split in Croatia. The investigators plan to enrol 100 patients, randomly assigned to suture-based wound closure (n=50) or tissue adhesive-based wound closure (n=50) with two-component skin adhesive Glubran Tiss 2®. The neurological outcomes will assessed postoperatively during the follow-up period at intervals of 2, 6, and 12 weeks respectively.
详细描述
All surgical procedures will be performed with a tourniquet and local anaesthesia using 2% lidocaine in the palmar soft tissues and carpal tunnel. For all subjects, the standard carpal canal decompression procedure will began withskin incision in the radial half of the palm, followed by carpal ligament transection and cutting. Following primary closure, two different techniques were used depending on the subject's randomization group:
- The skin will be stitched with transcutaneous nylon sutures (polypropylene-polyethylene monofilament, non-absorbable surgical suture) 4-0.
- After subcutaneous stitches with 4-0 Coated VicrylTM Plus PS-2, 3/8 ; a two-component skin adhesive, Glubran Tiss 2® will be applied. Each subject will received 0.35 mL of Glubran Tiss® in the open wound, and before bandaging, subjects rested for 20 seconds for a polymerization process.
The neurological outcomes will assessed postoperatively during the follow-up period at intervals of 2, 6, and 12 weeks respectively.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(all of the above)
- •age >18 years
- •carpal tunnel syndrome
- •weakness of thumb abduction
- •with atrophy of the thenar
- •median nerve conduction impairment estimated by electromyography
排除标准
- •(one or more)
- •threatening haemorrhagic complications (patients with peroral anticoagulation and/or antithrombotic therapy)
- •previous wrist trauma or surgery on the wrist region
- •another aetiology of neuropathy
- •previous allergic reactions (with lidocaine, cyanoacrylate, formaldehyde, tapes, or adhesives)
- •personal or family history of keloids or hypertrophic scars
- •severe general illness with cachexia
结局指标
主要结局
median nerve sensory values measured electromyographic (EMG)
时间窗: 2 months
- median nerve latency (msec)
次要结局
- Total EMG severity classification(2 months)
- median nerve motoric values measured electromyographic (EMG)(2 months)
研究者
Vedran Kovacic
Profesor of Medicine
University of Split, School of Medicine