The Role of Topical Antibiotic Prophylaxis in Eyelid Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 401
- 试验地点
- 1
- 主要终点
- Number of Participants With Surgical Site Infections
研究概览
简要总结
The investigators propose a prospective randomized control trial testing the hypothesis that routine topical antibiotic prophylaxis does not significantly reduce the rate of infection after eyelid surgery.
详细描述
The use of prophylactic topical antibiotic therapy after eyelid surgery is widespread. Due to increasing antibiotic resistance, antibiotic-related complications, and healthcare costs, the investigators wish to determine whether prophylactic post-operative antibiotic ointment is truly necessary. After all, existing dermatology literature currently recommends against the routine use of antibiotic ointment after various surgical procedures (e.g. Mohs surgery). The investigators aim to perform a prospective randomized control trial at the University of California, San Francisco. The investigators aim to recruit a total of 400 oculoplastics patients undergoing eyelid surgery or surgery involving peri-orbital incisions from 2017 through 2019.
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
盲法说明
Randomization to one of two intervention arms (i.e. antibiotic ointment vs. placebo artificial tear ointment) will be performed prior to study recruitment by REDCap software. Patients' randomization assignments will be revealed at the initial pre-operative visit or at time that procedure consent is obtained; the study team will not be aware of a subject's randomization assignment prior to that time.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18 and older who are undergoing various eyelid procedures in an office, ambulatory care center, or operating room including but not limited to:
- •blepharoplasty (upper and lower lids);
- •ectropion repair;
- •entropion repair;
- •external dacryocystorhinostomy;
- •external levator resection;
- •eyelid lesion removal and/or biopsy;
- •eyelid reconstruction and defect repair including after Mohs surgery;
- •fat pad excision (upper and lower lids);
- •gold or platinum weight implantation;
- •internal levator resection;
- •lateral tarsal strip;
- •orbital fracture repair requiring periorbital incisions;
- •orbitotomy requiring periorbital incisions;
- •tarsorrhaphy;
- •wedge excision.
- •Patients undergoing repeat procedures will also be included.
排除标准
- •Patients aged younger than 18 years old who are undergoing the above eyelid procedures in an office, ambulatory care centers, operating rooms;
- •patients undergoing chalazion removal;
- •patients who have had previous wound infections at the site of the procedure;
- •patients with oral or IV antibiotic use within 10 days prior to procedure;
- •patients requiring IV antibiotics during the procedure;
- •patients with grossly contaminated or inflamed wounds;
- •patients with human or animal bites, patients with wounds resulting from trauma
- •patients allergic to all study drug options.
研究组 & 干预措施
Topical Antibiotic Ointment
Intervention: 200 patients in the antibiotic arm will receive either erythromycin or bacitracin, based on allergies, surgeon preference, and antibiotic availability. If neither antibiotic is obtainable by the patient, bacitracin polymyxin will be prescribed instead. Antibiotic ointment is to be applied to the surgical incision(s) 4 times daily for 1 week.
干预措施: Topical Antibiotic Product (Drug)
Topical Non-Antibiotic Ointment
Intervention: 200 patients in the placebo group will receive mineral oil/petrolatum-based artificial tear ointment to be applied to the surgical incision(s) 4 times daily for 1 week.
干预措施: Topical Non-Antibiotic Ointment (Drug)
结局指标
主要结局
Number of Participants With Surgical Site Infections
时间窗: First Post-Operative Visit (~7-14 days)
The rate of superficial incisional or deep incisional surgical site infection (SSI) of clean and clean-contaminated wounds.
次要结局
- Number of Participants With Allergic Contact Dermatitis(First Post-Operative Visit (~7-14 days))
- Number of Participants With Wound Dehiscence(First Post-Operative Visit (~7-14 days))
- Number of High Risk Participants With Surgical Site Infections(First Post-Operative Visit (~7-14 days))