Topical Vancomycin for Craniotomy Wound Prophylaxis

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)的情况。在任何一家机构接受开颅手术的成年患者都有资格参加这项随机对照试验。随机分为治疗组，用万古霉素粉剂3 mg，与生理盐水混合成糊状，贴于开颅骨瓣缘，闭合前贴于皮缘。对照组的受试者将接受目前标准的护理，而不是局部治疗 万古霉素。所有受试者在手术前、手术后10-14天和手术后90天分别用棉签擦拭前鼻孔和手术部位。主要的结果测量将是手术部位感染，在住院期间每天进行评估，在第一次随访时进行，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小时对每个患者的全身万古霉素水平进行评估。有脑室外引流的患者每天都会接受万古霉素水平的评估。在放置了颅底引流管的患者中，将从每天开始分析伤口引流中万古霉素的浓度。将分析皮肤和鼻部菌群，以评估外用万古霉素对患者微生物群的影响。手术部位感染(SSI)发生在高达5%的开颅手术中，其特点是发病率和死亡率高，再次手术需要增加，住院时间更长，医疗费用增加。尽管预防性静脉注射抗生素、适当的无菌技术和其他干预措施导致开颅术后感染的发生率有所下降，但SSIs继续显著影响发病率、死亡率和成本负担。尽管从来没有在开颅手术中进行过研究，但在伤口闭合前将万古霉素局部应用于手术部位已经显示出脊柱、心脏和眼科手术中SSI的减少。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了药物的全身水平，因此减少了与药物有关的不良事件的可能性，如在本地菌群中诱导耐药性。我们提出了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。

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.