Topical Vancomycin for Craniotomy Wound Prophylaxis

外用万古霉素用于预防开颅手术伤口

基本信息

项目摘要

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(由申请方提供):本研究是NYP-Columbia和NYP-Cornell之间的合作,旨在评价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)的作用。在任一机构接受开颅术的成人患者将有资格参加本随机对照试验。随机分配至治疗组的患者将接受3 mg万古霉素粉末,与生理盐水混合制成糊剂,并在闭合前应用于骨开颅术边缘,然后应用于皮肤边缘。对照组中的受试者将接受当前标准治疗,不接受局部给药。 万古霉素所有受试者将在术前、术后10-14天和术后90天对前鼻孔和手术部位进行擦拭。主要结局指标将是手术部位感染,在住院期间每天进行评估,在首次随访访视时进行评估,并在30天时通过电话进行评估。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小时评估每例患者的全身万古霉素水平。脑室外引流到位的患者将每天评估万古霉素水平。在放置颅骨引流管的患者中,将从每日伤口引流液中分析万古霉素浓度。将分析皮肤和鼻腔植物群,以评估局部万古霉素对患者微生物组的影响。手术部位感染(SSI)在开颅手术中的发生率高达5%,其特点是发病率和死亡率高,再次手术的需求增加,住院时间延长和医疗费用增加。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SSI仍会显著影响发病率、死亡率和成本负担。虽然从未在开颅手术中进行过研究,但在伤口闭合前将万古霉素局部应用于手术部位已证明可减少脊柱、心脏和眼科手术中的SSI。与静脉注射相比,预防性局部使用万古霉素的益处包括降低药物的全身水平,因此降低与药物相关的不良事件的概率,例如诱导天然植物群的耐药性。我们提出一项随机对照试验,以评估局部万古霉素在降低开颅手术后SSI发生率方面的有效性。

项目成果

期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)

数据更新时间:{{ journalArticles.updateTime }}

{{ item.title }}
{{ item.translation_title }}
  • DOI:
    {{ item.doi }}
  • 发表时间:
    {{ item.publish_year }}
  • 期刊:
  • 影响因子:
    {{ item.factor }}
  • 作者:
    {{ item.authors }}
  • 通讯作者:
    {{ item.author }}

数据更新时间:{{ journalArticles.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ monograph.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ sciAawards.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ conferencePapers.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ patent.updateTime }}

EDWARD SANDER CONNOLLY其他文献

EDWARD SANDER CONNOLLY的其他文献

{{ item.title }}
{{ item.translation_title }}
  • DOI:
    {{ item.doi }}
  • 发表时间:
    {{ item.publish_year }}
  • 期刊:
  • 影响因子:
    {{ item.factor }}
  • 作者:
    {{ item.authors }}
  • 通讯作者:
    {{ item.author }}

{{ truncateString('EDWARD SANDER CONNOLLY', 18)}}的其他基金

Stroke Trials Network of Columbia and Cornell
哥伦比亚大学和康奈尔大学中风试验网络
  • 批准号:
    10767024
  • 财政年份:
    2023
  • 资助金额:
    $ 48.73万
  • 项目类别:
Stroke Trials Network of Columbia and Cornell
哥伦比亚大学和康奈尔大学中风试验网络
  • 批准号:
    9571820
  • 财政年份:
    2018
  • 资助金额:
    $ 48.73万
  • 项目类别:
Stroke Trials Network of Columbia and Cornell
哥伦比亚大学和康奈尔大学中风试验网络
  • 批准号:
    9983213
  • 财政年份:
    2018
  • 资助金额:
    $ 48.73万
  • 项目类别:
Stroke Trials Network of Columbia and Cornell
哥伦比亚大学和康奈尔大学中风试验网络
  • 批准号:
    10468292
  • 财政年份:
    2018
  • 资助金额:
    $ 48.73万
  • 项目类别:
Stroke Trials Network of Columbia and Cornell
哥伦比亚大学和康奈尔大学中风试验网络
  • 批准号:
    9764512
  • 财政年份:
    2018
  • 资助金额:
    $ 48.73万
  • 项目类别:
Stroke Trials Network of Columbia and Cornell
哥伦比亚大学和康奈尔大学中风试验网络
  • 批准号:
    10306036
  • 财政年份:
    2018
  • 资助金额:
    $ 48.73万
  • 项目类别:
Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial - Hemodynamics (CREST-H)
无症状颈动脉狭窄试验的颈动脉血运重建和医疗管理 - 血流动力学 (CREST-H)
  • 批准号:
    9311842
  • 财政年份:
    2017
  • 资助金额:
    $ 48.73万
  • 项目类别:
Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial - Hemodynamics (CREST-H)
无症状颈动脉狭窄试验的颈动脉血运重建和医疗管理 - 血流动力学 (CREST-H)
  • 批准号:
    9923010
  • 财政年份:
    2017
  • 资助金额:
    $ 48.73万
  • 项目类别:
Statin Neuroprotection & Cognitive Dysfunction after Carotid Endarterectomy: Safety, Feasibility, & Outcomes.
他汀类药物神经保护
  • 批准号:
    9176594
  • 财政年份:
    2016
  • 资助金额:
    $ 48.73万
  • 项目类别:
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
  • 财政年份:
    2014
  • 资助金额:
    $ 48.73万
  • 项目类别:

相似海外基金

A Randomized Clinical Trial of Continuous vs. Intermittent Infusion Vancomycin: Effects on Measured GFR and Kidney Injury Biomarkers
连续与间歇输注万古霉素的随机临床试验:对测量的 GFR 和肾损伤生物标志物的影响
  • 批准号:
    10647236
  • 财政年份:
    2023
  • 资助金额:
    $ 48.73万
  • 项目类别:
Deep Learning Based Pharmacokinetic Model for Vancomycin
基于深度学习的万古霉素药代动力学模型
  • 批准号:
    10804308
  • 财政年份:
    2023
  • 资助金额:
    $ 48.73万
  • 项目类别:
Elucidating the temporal mechanism of vancomycin kidney toxicity as a means to prevent injury
阐明万古霉素肾毒性的时间机制作为预防损伤的手段
  • 批准号:
    10727172
  • 财政年份:
    2023
  • 资助金额:
    $ 48.73万
  • 项目类别:
Context-specific modulation of Clostridioides difficile virulence by Vancomycin-resistant Enterococcus faecium
耐万古霉素屎肠球菌对艰难梭菌毒力的特定调节
  • 批准号:
    10629341
  • 财政年份:
    2022
  • 资助金额:
    $ 48.73万
  • 项目类别:
Context-specific modulation of Clostridioides difficile virulence by Vancomycin-resistant Enterococcus faecium
耐万古霉素屎肠球菌对艰难梭菌毒力的特定调节
  • 批准号:
    10511292
  • 财政年份:
    2022
  • 资助金额:
    $ 48.73万
  • 项目类别:
Adaptation of vancomycin-resistant enterococci during bloodstream infection
血流感染期间耐万古霉素肠球菌的适应
  • 批准号:
    10634721
  • 财政年份:
    2022
  • 资助金额:
    $ 48.73万
  • 项目类别:
Characterizing Vancomycin-Resistant C. difficile Strains at Two Geographically Distinct Locations
两个不同地理位置的耐万古霉素艰难梭菌菌株的特征
  • 批准号:
    10380182
  • 财政年份:
    2021
  • 资助金额:
    $ 48.73万
  • 项目类别:
Characterizing Vancomycin-Resistant C. difficile Strains at Two Geographically Distinct Locations
两个不同地理位置的耐万古霉素艰难梭菌菌株的特征
  • 批准号:
    10595072
  • 财政年份:
    2021
  • 资助金额:
    $ 48.73万
  • 项目类别:
Vancomycin-resistant Enterococcus Colonization and Liver Transplantation
耐万古霉素肠球菌定植和肝移植
  • 批准号:
    466737
  • 财政年份:
    2021
  • 资助金额:
    $ 48.73万
  • 项目类别:
    Studentship Programs
Characterizing Vancomycin-Resistant C. difficile Strains at Two Geographically Distinct Locations
两个不同地理位置的耐万古霉素艰难梭菌菌株的特征
  • 批准号:
    10211571
  • 财政年份:
    2021
  • 资助金额:
    $ 48.73万
  • 项目类别:
{{ showInfoDetail.title }}

作者:{{ showInfoDetail.author }}

知道了