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: 8674351
• 负责人: EDWARD SANDER CONNOLLY
• 金额: $ 48.73万
• 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: 2014-07-01 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8674351
• 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在开颅手术中减少手术部位感染 (SSI) 的效果。在任一机构接受开颅手术的成年患者将有资格参加这项随机对照试验。随机分配到治疗组的患者将接受 3 毫克万古霉素粉末，与生理盐水混合制成糊剂，涂在骨开颅边缘，然后在闭合前涂在皮肤边缘。对照组中的受试者将接受当前标准的护理，无需局部用药 万古霉素。所有受试者将在手术前、手术后 10-14 天和手术后 90 天接受前鼻孔和手术部位的拭子检查。主要结果指标是手术部位感染，在住院期间、首次随访时以及 30 天时通过电话进行每日评估。次要结局包括住院时间、重症监护时间、再手术率和患者死亡率。此外，将在术后 6 小时和 24 小时评估每位患者的全身万古霉素水平。设有脑室外引流管的患者将每天评估万古霉素水平。对于放置颅脑引流管的患者，每天分析伤口引流管中的万古霉素浓度。将分析皮肤和鼻腔菌群，以评估局部万古霉素对患者微生物组的影响。高达 5% 的开颅手术中会发生手术部位感染 (SSI)，其特点是发病率和死亡率高、再次手术需求增加、住院时间更长以及医疗费用增加。尽管由于预防性静脉注射抗生素、适当的无菌技术和其他干预措施，开颅手术后继发感染的发生率有所下降，但 SSI 继续显着影响发病率、死亡率和成本负担。虽然从未在开颅手术中进行过研究，但在伤口闭合之前在手术部位局部使用万古霉素已证明可以减少脊柱、心脏和眼科手术中的 SSI。与静脉注射相比，局部使用预防性万古霉素的好处包括降低药物的全身水平，从而降低与药物相关的不良事件的可能性，例如诱导天然菌群的耐药性。我们提出一项随机对照试验来评估外用万古霉素在降低开颅手术后 SSI 发生率方面的有效性。