Lucerne Cantonal Hospital, Orthopedic and Trauma Surgery, Lucerne, Switzerland.
Clinical Trial Unit Central Switzerland and its Head of Biostatistics and Methodology, Lucerne, Switzerland.
Trials. 2020 Feb 19;21(1):205. doi: 10.1186/s13063-020-4087-8.
Temporary fixation with an external fixator is used for numerous indications in orthopedic trauma surgery. It is unclear whether primary wound healing or secondary open-wound healing after removal of the external fixator should be advocated for the pin site. This study compares primary wound closure with secondary wound healing for the pin site. The primary aim is to compare pin-site infection rates. The secondary aim is to compare time to wound healing and esthetic outcome. The hypothesis was that primary wound closure does not lead to more infections than secondary wound healing.
This is a prospective, randomized controlled, blinded, monocenter study based on a non-inferiority design. To obtain an equal patient population and groups, all pin-entry sites of the patients are treated alternately at the time of removal of the external fixator with primary wound closure and secondary wound healing. Patients are randomized according to whether the proximal pin-entry site is treated with wound closure or by secondary open-wound healing, from which the further sequence develops. The pre- and postoperative protocol is standardized for all pin-entry sites. A photo documentation of the pin-entry sites takes place 2 and 52 weeks postoperatively during the routine clinical follow-up visits. Further controls take place at 6, 12 and 26 weeks after pin removal. The primary outcome was to demonstrate the non-inferiority of primary wound closure compared to secondary wound healing in terms of postoperative wound infections according to the Center of Disease Control and Prevention (CDC) definitions. The secondary outcomes are time to complete wound healing (days) and esthetical outcome (subjective preference of patients and Vancouver Scar Scale score).
This study aims to answer how to deal with the pin site after removal of the external fixator. To date, no routine and generally accepted protocol exists for the management of pin sites after removal of the external fixator. This prospective, randomized controlled, blinded monocenter trial should determine whether primary wound closure or secondary wound healing should be advocated after removal of the external fixator.
ClinicalTrials.gov, ID: NCT03842956. Registered retrospectively on 13 February 2019.
在骨科创伤手术中，临时外固定器固定被广泛应用于多种适应症。目前尚不清楚，在去除外固定器后，究竟是应提倡针道的原发性伤口愈合还是二期开放性伤口愈合。本研究比较了针道的一期闭合与二期愈合。主要目的是比较针道感染率。次要目的是比较伤口愈合时间和美观效果。假设是一期伤口闭合不会导致比二期愈合更多的感染。
这是一项基于非劣效性设计的前瞻性、随机对照、盲法、单中心研究。为了获得相等的患者人群和分组，所有患者的外固定器去除时的针道入口都交替采用一期伤口闭合和二期伤口愈合治疗。患者根据近端针道入口是采用伤口闭合还是二期开放性伤口愈合治疗进行随机分组，进一步的分组顺序由此产生。所有针道入口都按照标准化的术前和术后方案进行处理。在常规临床随访中，在术后 2 周和 52 周对针道入口进行照片记录。在去除针后 6、12 和 26 周进行进一步的随访。主要结局是根据疾病预防控制中心（CDC）的定义，证明一期伤口闭合与二期伤口愈合相比在术后伤口感染方面的非劣效性。次要结局是完全愈合时间（天）和美观效果（患者的主观偏好和温哥华瘢痕量表评分）。
本研究旨在回答在去除外固定器后如何处理针道的问题。迄今为止，对于去除外固定器后的针道处理尚无常规和普遍接受的方案。这项前瞻性、随机对照、盲法、单中心试验应确定在去除外固定器后，应提倡一期伤口闭合还是二期伤口愈合。
ClinicalTrials.gov，编号：NCT03842956。于 2019 年 2 月 13 日进行了回顾性注册。
