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）：本研究是纽约大学哥伦比亚分校和纽约大学康奈尔分校的合作研究，旨在评估外用万古霉素在开颅手术中对手术部位感染（SSI）的减少。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。随机分配到治疗组的患者给予万古霉素粉剂3mg，与生理盐水混合制成膏状，在骨开颅边缘涂抹，闭合前涂抹于皮肤边缘。对照组的受试者将接受目前标准的护理，不进行局部治疗