Topical Antibiotic Treatment for Spine Surgical Site Infections

 描述(申请人提供)：脊柱手术后的手术部位感染(SSI)是一种毁灭性的并发症，现在被付款人归类为“从未发生过的事件”，因为它被推定为质量失误的结果。脊椎SSI每年在多达40,000人中发生，导致相当大的残疾和系统成本，重新手术经常超过100,000美元。即使使用标准的围手术期感染预防技术，SSI的发生率也高达3%-5%。预防SSI的主要方法是抗生素治疗，但由于抗生素在骨组织中的浓度低于血液中的浓度，因此伤口内抗生素(IWA)的使用越来越受到人们的关注，手术完成后直接放在脊柱上就出现了SSI。由于SSI的发生频率相对较低，IWA技术在医院和外科医生水平上的差异，IWA的广泛应用是否真的会降低脊柱SSI的发生率仍有待确定。需要一项具有适当随访期的IWA的大规模试验来评估其在脊柱手术中的有效性。利用脊柱外科护理和结果评估计划(Spine SCOAP)-比较有效性研究翻译网络(SENCE)网络以及华盛顿的综合医院摘要报告系统，我们将进行一系列研究，以支持IWA的适当试验。为此，我们建议：目标1：使用链接的Spine SCOAP-CHARS数据集，测试脊柱融合后30、90、180和360天SSI发生率的差异，以及接受和未接受IWA的患者之间的差异；目标2：比较关于IWA的知识、信念和态度与Spine SCOAP-某些医院的外科医生实际使用IWA的情况；以及目标3：评估参与未来试验的意愿，并使用Spine SCOAP-某些医院设计有效的CRCT。这项研究汇集了一支真正的多学科专家团队，他们在脊柱外科、比较有效性研究、公共卫生、SSI预防、CRCT生物统计学、流行病学、患者报告结果等领域合作超过10年。这组试点和可行性研究的结果将支持在Spine SCOAP-某些网络内进行CRCT的设计和实施，并/或通知考虑进行此类试验的其他研究人员。最终，这些研究应该确定在标准感染预防方案中加入IWA以避免脊柱手术后SSI的有效性。证明IWA是有效的，将代表着脊柱外科实践的重大转变，并将直接惠及每年数千名患者。

 DESCRIPTION (provided by applicant): Surgical site infection (SSI) after spine surgery is a devastating complication, now classified as a "never event" by payers, because it is presumed to be the result of a lapse in quality. Spine SSIs occur in as many as 40,000 people each year, resulting in considerable disability and costs to the system, with reoperations often over $100,000. Even with the use of standard perioperative infection prevention techniques, SSIs occur in as many as 3-5%. A mainstay of SSI prevention is antibiotic treatment, but because antibiotic concentrations are lower in bone tissue than blood levels, there has been increasing interest in the use of in-wound antibiotics (IWA), placed directly on the spine at the completion of surgery to advent spine SSI. Because of the relative infrequency of SSI and variation in IWA techniques at both the hospital- and surgeon-level, it remains to be determined if the broad use of IWA would actually decrease rates of spine SSI. A large scale trial of IWA with an appropriate follow-up period is needed to evaluate its effectiveness in spine surgery. Leveraging the Spine Surgical Care and Outcomes Assessment Program (Spine SCOAP)-Comparative Effectiveness Research Translation Network (CERTAIN) network in conjunction with Washington's Comprehensive Hospital Abstract Reporting System, we will perform a set of studies that should support an appropriate trial of IWA. The accomplish this we propose: Aim 1: Test differences in the incidence of SSI at 30, 90, 180 and 360-days after spine fusion, overall and among those who do and do not receive IWA using a linked Spine SCOAP-CHARS dataset; Aim 2: Compare knowledge, beliefs and attitudes about IWA with the actual use of IWA by surgeons in Spine SCOAP-CERTAIN hospitals , and Aim 3: Assess willingness to take part in a future trial and design an efficient cRCT using Spine SCOAP-CERTAIN hospitals. This research brings together a truly multidisciplinary team of experts in spine surgery, comparative effectiveness research, public health, SSI prevention, cRCT biostatistics, epidemiology, patient-reported outcomes who have been working together for over 10 years. The results of this set of pilot and feasibility studies will support the design and conduct of a cRCT within the Spine SCOAP-CERTAIN network and/or inform other researchers considering such a trial. Ultimately, these studies should determine the effectiveness of adding IWA to standard infection prevention regimens to avoid SSI after spine surgery. Demonstrating that IWA is effective would represent a major shift in the practice of spine surgery and have direct benefits to thousands of patients each year.