Greig A, Gardiner M D, Sierakowski A, Zweifel C J, Pinder R M, Furniss D, Cook J A, Beard D, Farrar N, Cooper C D, Jain A
Department of Plastic Surgery, Guy's and St Thomas' NHS Foundation Trust, London, UK.
Department of Surgery and Cancer, Imperial College London, London, UK.
Br J Surg. 2017 Nov;104(12):1634-1639. doi: 10.1002/bjs.10673.
Nail-bed injuries are the most common hand injury in children. Surgical dogma is to replace the nail plate after repairing the nail bed. Recent evidence suggests this might increase infection rates and returns to clinic. The aim of this feasibility trial was to inform the design and conduct of a definitive trial comparing replacing or discarding the nail plate after nail-bed repair.
This study recruited participants from four hand units in the UK between April and July 2015. Participants were children under the age of 16 years with a nail-bed injury requiring surgery. They were randomized to either having the nail plate replaced or discarded after nail-bed repair. The follow-up method was also allocated randomly (postal versus clinic). Information was collected on complications at 2 weeks and 30 days, and on nail-plate appearance at 4 months using the Zook classification. Two possible approaches to follow-up were also piloted and compared.
During the recruitment phase, there were 156 potentially eligible children. Sixty were randomized in just over 3 months using remote web-based allocation. By 2 weeks, there were two infections, both in children with replaced nail plates. The nail-replaced group also experienced more complications. There was no evidence of a difference in return rates between postal and clinic follow-up.
Recruitment was rapid and nail-bed repair appeared to have low complication and infection rates in this pilot trial. The findings have led to revision of the definitive trial protocol, including the mode and timing of follow-up, and modification of the Zook classification.
甲床损伤是儿童最常见的手部损伤。外科手术原则是在修复甲床后更换甲板。最近的证据表明，这样做可能会增加感染率并导致再次就诊。这项可行性试验的目的是为一项比较甲床修复后更换或丢弃甲板的确定性试验的设计和实施提供依据。
本研究于2015年4月至7月在英国的四个手部治疗单元招募参与者。参与者为16岁以下需要进行甲床损伤手术的儿童。他们被随机分为甲床修复后更换或丢弃甲板两组。随访方式也随机分配（邮寄随访与门诊随访）。收集了2周和30天时的并发症信息，以及4个月时使用祖克（Zook）分类法评估的甲板外观信息。还对两种可能的随访方法进行了试点并比较。
在招募阶段，有156名潜在符合条件的儿童。在短短3个多月的时间里，通过基于网络的远程分配方法，60名儿童被随机分组。到2周时，出现了两例感染，均发生在更换甲板的儿童中。更换甲板组还出现了更多并发症。没有证据表明邮寄随访和门诊随访的复诊率存在差异。
在这项试点试验中，招募速度很快，甲床修复的并发症和感染率似乎较低。这些结果导致了确定性试验方案的修订，包括随访方式和时间，以及对祖克分类法的修改。
