Efficacy of Intranasal Povidone Iodine Swab Versus Oral Antibiotic Prophylaxis to Prevent Surgical Site Infections in Patients Undergoing Mohs Micrographic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 入组人数
- 1,532
- 主要终点
- Effectiveness of nasal decolonization with povidone-iodine versus a standardized oral antibiotic prophylaxis protocol to prevent surgical site infection (SSI)
研究概览
简要总结
The purpose of this study is to compare surgical site infection rates for patients treated with Mohs micrographic surgery after bilateral nasal swab with povidone iodine versus standard treatment including the use of a standardized oral antibiotic prophylaxis protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-pregnant, non-lactating/breastfeeding, non-incarcerated, English-speaking persons undergoing Mohs micrographic surgery (MMS) for malignant cutaneous neoplasms and receiving same-day defect repair by the MMS-performing surgeon
- •Able to provide written informed consent prior to initiation of any study-specific procedures
- •Able to swallow, retain, and absorb oral medications
- •All malignant cutaneous neoplasms will be included
排除标准
- •On antibiotic treatment or established intolerance or contraindication to povidone-iodine
- •Allergy to specific oral antibiotics that are utilized as part of the Mayo Clinic Antibiotic Prophylaxis protocol (cefalexin, azithromycin, clindamycin)
- •Requiring oral antibiotic therapy for prophylaxis postoperative infectious endocarditis or hematogenous total joint infection
- •Cases where skin reconstruction is performed with non-sterile gloves
- •Patients with lesions on the legs, as dilute vinegar soaks are standard practice and this would be a confounder for preventing surgical site infection
- •Patients at increased risk for severe infections, including patients on immunosuppressive medications and biologics, patients with a history of HIV infection, chronic lymphocytic leukemia, immunodeficiency syndromes, as well as patients with insulin-dependent diabetes mellitus
研究组 & 干预措施
Povidone Iodine nasal swab
Patients undergoing Mohs micrographic surgery (MMS) for malignant cutaneous neoplasms will receive nasal povidone-iodine swabs prior to skin reconstruction.
干预措施: Staphylococcus nasal swab (Diagnostic Test)
Povidone Iodine nasal swab
Patients undergoing Mohs micrographic surgery (MMS) for malignant cutaneous neoplasms will receive nasal povidone-iodine swabs prior to skin reconstruction.
干预措施: Povidone-Iodine Swabs (Other)
Oral antibiotic prophylaxis protocol (usual care)
Patients undergoing Mohs micrographic surgery (MMS) for malignant cutaneous neoplasms will receive standard of care, including the provision of an oral anti-staphylococcal antibiotic per the standardized Antibiotic Prophylaxis protocol currently used for clinical decision making in Dermatologic Surgery at Mayo Clinic Rochester.
干预措施: Staphylococcus nasal swab (Diagnostic Test)
Oral antibiotic prophylaxis protocol (usual care)
Patients undergoing Mohs micrographic surgery (MMS) for malignant cutaneous neoplasms will receive standard of care, including the provision of an oral anti-staphylococcal antibiotic per the standardized Antibiotic Prophylaxis protocol currently used for clinical decision making in Dermatologic Surgery at Mayo Clinic Rochester.
干预措施: Antibiotic (Drug)
结局指标
主要结局
Effectiveness of nasal decolonization with povidone-iodine versus a standardized oral antibiotic prophylaxis protocol to prevent surgical site infection (SSI)
时间窗: 30 days after MMS
Effectiveness of nasal decolonization will be assessed based on the presence of SSI within 30 days after Mohs micrographic surgery (MMS). SSI is defined by the United States Centers for Disease Control and Prevention as infection of the cutaneous and subcutaneous tissue occurring within 30 days of surgery. Rates of SSI for both treatment arms will be reported.
次要结局
未报告次要终点