Pan Am Clinic, 75 Poseidon Bay, Winnipeg, MB, R3M 3E4, Canada.
BMC Musculoskelet Disord. 2012 Jun 6;13:89. doi: 10.1186/1471-2474-13-89.
A recently published meta-analysis comparing metallic staples to sutures in orthopaedic procedures revealed three fold increase in risk for infection in stapled wounds. The studies included in the meta-analysis are at risk of bias due to experimental design limitations. A large randomized controlled trial is proposed to direct orthopaedic surgeons in their choice of wound closure material.
METHODS/DESIGN: A parallel group randomized controlled trial with institutional review board approval will be conducted. Patients will be randomized intraoperatively to have skin wounds closed with sutures or staples. Dressings will be used to maintain blinding outcome assessors. The primary outcome measure will be a composite all-cause wound complication outcome measure composed of: infection, wound drainage, wound necrosis, blistering, dehiscence, suture abscess and material sensitivity reaction. An independent review board blinded to treatment assignment will adjudicate suspected complications based on clinical data. All deceased patients will also be reviewed. An interim analysis of complications will take place after half of the patients have been recruited. All data will be analyzed by a blinded statistician. Dichotomous primary and secondary outcome measures will be analyzed using the Chi-squared statistic. Continuous outcome measures will be analyzed using Student's t-test. Subgroup analysis will compare infection rates using sutures versus staples in each anatomic area (upper extremity, pelvis/acetabulum, hip/femur, knee, ankle). A further subgroup analysis will be conducted comparing trauma patients to elective surgery patients. Non-infected revision surgery will also be compared to primary surgery.
Wound closure material is an afterthought for many orthopaedic surgeons. The combined results of several comparative trials suggests that the choice of wound closure materials may have an impact on the rate of surgical site infections. However, the strength of the evidence is poor given the heterogeneity of the methods employed in previous studies. The following study protocol aims to guide surgeons in their choice of wound closure material by determining if there is a difference in complication rates in sutured and stapled wounds.
This trial was registered at ClinicalTrials.gov under the identifier NCT01146236 (registered June 14, 2010).
最近发表的一项荟萃分析比较了骨科手术中使用金属钉和缝线，结果显示钉合伤口感染的风险增加了三倍。由于实验设计的局限性，纳入荟萃分析的研究存在偏倚风险。因此，我们提出一项大型随机对照试验，以指导骨科医生选择伤口闭合材料。
方法/设计：这项研究是一项具有机构审查委员会批准的平行组随机对照试验。患者将在手术中随机分为缝线或钉合皮肤伤口。使用敷料来保持评估结果的观察者的盲法。主要结局测量指标是由以下所有原因伤口并发症组成的综合结局测量指标：感染、伤口引流、伤口坏死、水疱、裂开、缝线脓肿和材料过敏反应。一个独立的审查委员会将根据临床数据对怀疑的并发症进行裁决，不了解治疗分配情况。所有死亡患者也将进行审查。在一半患者入组后，将进行并发症的中期分析。所有数据都将由盲法统计学家进行分析。二分类的主要和次要结局测量指标将使用卡方检验进行分析。连续结局测量指标将使用学生 t 检验进行分析。亚组分析将比较每个解剖区域（上肢、骨盆/髋臼、髋/股骨、膝、踝）中使用缝线与钉合的感染率。进一步的亚组分析将比较创伤患者和择期手术患者。非感染性翻修手术也将与初次手术进行比较。
对于许多骨科医生来说，伤口闭合材料是事后才考虑的。几项比较试验的综合结果表明，伤口闭合材料的选择可能会影响手术部位感染的发生率。然而，由于先前研究中使用的方法存在异质性，证据的强度较差。本研究旨在通过确定缝合和钉合伤口的并发症发生率是否存在差异，指导外科医生选择伤口闭合材料。
这项试验在 ClinicalTrials.gov 注册，标识符为 NCT01146236（2010 年 6 月 14 日注册）。
