A Comparative Assessment Between Two Surgical Sites of the Rate of Corneal Toxicity and Ototoxicity With the Use of Povidone-iodine Versus Chlorhexidine-alcohol for Facial Lesions Treated With Mohs Micrographic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Ocular and Ear Toxicities
研究概览
简要总结
Does the use of chlorhexidine scrub prior to cutaneous surgery on the face increase the chances of toxicity to the eyes or ears? In addition, does the us eof chlorhexidine scrub on the face prior to cutaneous surgery decrease the chances of a post-operative wound infection?
详细描述
The intent of this proposed prospective observational cohort study is to determine if there is a difference in the incidence of corneal toxicity and/or ototoxicity in study subjects undergoing Mohs micrographic surgery (MMS) on the face if a povidone-iodine preparation is used pre-operatively as compared to a chlorhexidine-alcohol preparation. It has recently been found that the use of a chlorhexidine-alcohol preparation is superior to the use of a povidone-iodine preparation in preventing post-operative surgical-site infections (SSI) in patients undergoing clean-contaminated surgery. However, the use of chlorhexidine on the face has previously been associated with corneal toxicity and ototoxicity. This study will help to further define previously reported risks of corneal toxicity and ototoxicity associated with the use of a chlorhexidine solution on the face.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 undergoing an outpatient cutaneous surgical procedure on the face.
排除标准
- •Those who do not consent to participation
- •Those undergoing cutaneous surgery for a lesion on the eyelid margin
- •Patients with a history of ongoing eye pain
- •History of a pre-existing corneal ulcer within 12 months prior to surgery
- •History of a perforated tympanic membrane
- •Patients with an active infection at the surgical site at the time of surgery.
- •If post-operative follow-up is not completed, the study subject will be excluded from the analysis.
结局指标
主要结局
Ocular and Ear Toxicities
时间窗: 1 year
Comparing ocular and ear toxicities between two institutions with differences in aseptic technique.
次要结局
- Infection rates(1 year)
研究者
Jerry Brewer
Associate Professor of Dermatology
Mayo Clinic