Topical Antibiotic Treatment for Spine Surgical Site Infections

脊柱手术部位感染的局部抗生素治疗

• 批准号: 9137604
• 负责人: David R Flum
• 金额: $ 14.24万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-15 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9137604
• 关键词: Accounting; Address; Antibiotic Prophylaxis; Antibiotic Therapy; Antibiotics; Attitude; Belief; Benchmarking; Biometry; Blood; Bone Tissue; Caring; Characteristics; Clinical; Complication; Data; Data Set; Databases; Detection; Dose; Effectiveness; Epidemiology; Evaluation; Event; Feasibility Studies; Future; Goals; Health; Health Knowledge, Attitudes, Practice; Hospitals; Incidence; Infection; Infection prevention; Intravenous; Knowledge; Link; Operative Surgical Procedures; Outcome; Outcome Assessment; Patient Outcomes Assessments; Patients; Perioperative; Pilot Projects; Process; Provider; Public Health; Randomized; Randomized Controlled Trials; Regimen; Repeat Surgery; Reporting; Research; Research Personnel; Risk; Role; Site; Spine surgery; Surgeon; Surveys; System; Techniques; Testing; Time; Topical Antibiotic; Translations; Uncertainty; Variant; Vertebral column; Washington; Work; abstracting; base; comparative effectiveness; cost; design; disability; effectiveness research; follow-up; implementation science; indexing; interest; multidisciplinary; pragmatic trial; programs; prospective; protective effect; systematic review; trial design; willingness; wound

 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.

 描述（由适用提供）：脊柱手术后的手术部位感染（SSI）是一种破坏并发症，现在被付款人归类为“永不事件”，因为它是质量流逝的结果。脊柱SSI每年发生多达40,000人，导致系统残疾和系统成本，重新运作通常超过100,000美元。即使使用标准周期性感染预防技术，SSI也发生在多达3-5％的范围内。 SSI预防的支柱是抗生素治疗，但是由于骨骼组织中的抗生素浓度低于血液水平，因此人们对使用连接抗生素（IWA）的兴趣越来越高，在手术完成时直接放置在脊柱上，以推进脊柱SSI。由于医院和外科医生水平的IWA技术的SSI相对频率相对不频率，因此是否实际上会降低脊柱SSI的速率，尚待确定。需要对具有适当随访期的IWA进行大规模试验，以评估其在脊柱手术中的有效性。利用脊柱手术护理和结果评估计划（脊柱scap） - 比较有效性研究翻译网络（某些）网络，并与华盛顿的综合医院摘要报告系统结合使用，我们将进行一系列研究，应支持适当的IWA试验。我们提出的成就：AIM 1：SSI事件的测试差异在脊柱融合后的30、90、180和360天，整体上以及那些使用链接的脊柱scoap-coap-chars数据集接受和不接收IWA的人；目标2：比较知识，相信和参加有关IWA的知识与脊柱scoap coap caption医院的外科医生实际使用IWA，并瞄准3：评估愿意参加以后的试验并使用脊柱Scoap-coap contair nospitals进行有效的CRCT。这项研究汇集了一个真正多学科的脊柱手术专家团队，比较有效性研究，公共卫生，预防SSI，CRCT生物统计学，流行病学，与患者报告的结果已经共同努力了10多年。这组试点和可行性研究的结果将支持脊柱sc片coap-coap-copnition网络中的​​CRCT和/或考虑此类试验的其他研究人员。最终，这些研究应确定将IWA添加到标准感染预防方案中以避免脊柱手术后避免SSI的有效性。证明IWA是有效的，这将代表脊柱手术实践的重大转变，并且每年对成千上万的患者有直接的好处。