Topical Vancomycin for Craniotomy Wound Prophylaxis

外用万古霉素用于预防开颅手术伤口

• 批准号: 8868935
• 负责人: EDWARD SANDER CONNOLLY
• 金额: $ 49.88万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-01 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8868935
• 关键词: Topical; Vancomycin; Craniotomy; Wound; Prophylaxis

DESCRIPTION (provided by applicant): This study is a collaboration between NYP-Columbia and NYP-Cornell that seeks to evaluate the use of topical vancomycin and its reduction on surgical site infection (SSI) in craniotomy procedures. Adult patients undergoing craniotomy at either institution will be eligible for participation in this randomized control trial. Patients randomized to the treatment group will receive 3mg of vancomycin powder, mixed with normal saline to make a paste, and applied to the bone craniotomy edges then to the skin edges prior to closure. Subjects in the control group will receive the current standard of care without topical vancomycin. All subjects will undergo swabbing of the anterior nares and the surgical site prior to surgery, once 10-14 days following the operation and 90 days following the operation. The primary outcome measure will be surgical site infection, assessed daily throughout the hospital stay, at the first follow-up visit, and by telephone at 30 days. Secondary outcomes will include length of hospital stay, length of intensive care stay, rate of reoperation and patient mortality. n addition, systemic vancomycin levels will be assessed at 6 hours and 24 hours postoperatively in each patient. Patients who have an external ventricular drain in place will have vancomycin levels assessed daily. In patients who have cranial drains placed, vancomycin concentrations will be analyzed from daily in wound drainage. Skin and nasal flora will be analyzed to assess the impact of topical vancomycin on the patient microbiome. Surgical site infections (SSIs) occur in up to 5% of craniotomy procedures, and are characterized by high morbidity and mortality, increased need for reoperation, longer hospital length of stay and increased healthcare costs. Although there has been a decrease in the incidence of infections following craniotomy secondary to prophylactic intravenous antibiotics, proper sterile techniques, and other interventions, SSIs continue to significantly impact morbidity, mortality, and cost burden. Although never studied in craniotomy procedures, the application of topical vancomycin to the surgical site prior to wound closure has demonstrated a reduction in SSIs in spine, cardiac and ophthalmologic procedures. The benefits of using prophylactic vancomycin topically, as opposed to intravenously, include reduced systemic levels of the drug, and therefore, a decreased probability of adverse events related to the drug, such as inducing resistance among native flora. We propose a randomized control trial to evaluate the effectiveness of topical vancomycin in reducing SSIs rates following craniotomy procedures.

描述（由申请人提供）：这项研究是NYP-Columbia和NYP-Cornell之间的合作，旨在评估局部万古霉素的使用及其对手术部位感染（SSI）在颅骨切开术中的使用。在这两家机构进行颅骨切开术的成年患者将有资格参加这项随机对照试验。随机分配给治疗组的患者将接受3mg的万古霉素粉末，并与正常盐水混合以制成糊状，并在关闭前将其应用于骨颅骨移动边缘，然后在骨颅骨边缘上粘贴到皮肤边缘。对照组中的受试者将获得当前的护理标准，而无需局部 万古霉素。所有受试者将在手术前10-14天和手术后的90天进行手术前的前鼻孔和手术部位擦拭。主要结局措施将是手术现场感染，每天在整个医院住院，第一次随访时进行评估，并在30天后通过电话进行评估。次要结果将包括住院时间，重症监护室的长度，重新手术率和患者死亡率。 n补充，每位患者的全身万古霉素水平将在术后6小时24小时评估。有外部室排水的患者每天将评估万古霉素水平。在放置颅底的患者中，将从伤口引流中分析万古霉素的浓度。将分析皮肤和鼻腔菌群，以评估局部穿万古霉素对患者微生物组的影响。手术部位感染（SSIS）发生在高达5％的颅骨手术过程中，其特征是发病率高和死亡率，重新手术的需求增加，住院时间较长以及医疗保健费用增加。尽管继发于预防性静脉抗生素，适当的无菌技术和其他干预措施之后的颅骨切开术后感染的发生率有所下降，但SSIS继续显着影响发病率，死亡率和成本负担。尽管从未在颅骨术程序中进行研究，但在伤口闭合之前，局部载体霉素在手术部位的应用表明，脊柱，心脏和眼科手术过程中的SSIS降低了。局部使用预防性万古霉素（而不是静脉注射）的好处包括药物的全身水平降低，因此，与该药物相关的不良事件的可能性降低，例如诱导天然菌群之间的抗性。我们提出了一项随机对照试验，以评估局部Vanomycin在颅骨术后降低SSIS速率方面的有效性。