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临床试验/NCT03013608
NCT03013608终止不适用

Children's Nail Bed Injuries : Study of the Efficacy of the Simple Relocation of Nail Plate

University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2017年5月22日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
7
试验地点
2
主要终点
Nail aesthetical results

研究概览

简要总结

Nail bed injuries in children, most frequently under 3 years-old, result in crush injuries. The frequency is around 34 percent of the children hand injuries (Claudet et al, 2007). The empirical reparation technique is the nail bed suture and the relocation of the nail plate. However, some authors think that suture the nail bed could increase the traumatism of the nail bed because of the needle, the crush by the clamps and by the stitches too tight (Langlois, Yam). An author has proposed, in a prospective, randomized clinical trial to treat the nail bed injuries with a glue: the 2-octylcyanoacrylate, without suture of the nail bed. Advantages of this technique, claimed by the author, was time saving, with an aesthetical result as same as the treatment with suture of the nail bed. A same study validated the technique in a paediatric population (Langlois et al., 2010). So, it seems that it is not necessary to suture the nail bed. But, in our practice, the investigators noted complications not mentioned in previous studies: hematomas causing pain, effusion and dislocation of the nail plate, with constrain the patient to consult in emergency. The 2-octylcyanoacrylate is difficult to use in nail bed injuries and is expensive. Our hypothesis is the simple relocation of the nail plate in nail bed injuries in paediatric population is enough to have good to excellent aesthetical results, with less complications and a lower cost, than the other techniques. The aim of this study is to assess the aesthetical results 3 months after simple relocation of the nail plate for nail bed injuries in children.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • age under 18 yo
  • nail bed injuries and/or nail matrix
  • nail plate > 30% of the surface comparing the opposite side
  • one or more digits
  • signature of the 2 parents
  • social security

排除标准

  • loss of more than 30% of the surface of the nail bed
  • Multiples lesions: nerve injury, tendon, fracture or luxation without indication of osteosynthesis, loss of skin with indication of a flap
  • osteosynthesis of the distal phalanx
  • injuries by bite
  • previous pathology of the nail
  • contraindication of Lidocaine, bicarbonate de sodium, Kalinox, Biseptine, Vicryl rapide, Adaptic
  • no information possible
  • pregnancy
  • breastfeeding
  • other inclusion in another study

结局指标

主要结局

Nail aesthetical results

时间窗: The evaluation is assessed at 6 months after the treatmen6

Evaluation with the Zook's scale at 6 months postoperative based on photographs of the injured finger compared with the finger on the opposite side. The evaluation will be done by five persons (surgeons, nurses, therapists....)

次要结局

  • Complications rate at short term (before 15 days): haematoma, infection, dislocation of the nail plate,: hook nail(at 15 days)
  • The pain with an analogic scale for children over 7 years-old,(at 6 months)
  • Satisfaction rate at 6 months, compared with the contralateral finger, by the children (if possible) and by parents, on a scale to 0 (not satisfied) to 10 (very satisfied).(at 6 months)
  • Complications rate: haematoma, infection, dislocation of the nail plate,at medium term (between 15 days and 3 months): hook nail(at 6 months)

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (2)

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