The Effect of Hair Removal on Intraoperative Contamination
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Intraoperative contamination rate
研究概览
简要总结
A prospective, non-blinded, randomized controlled trial with the purpose of investigating, whether preoperative electrical clipping of body hair affects the risk of intraoperative contamination.
The primary investigators hypothesis is this: Preoperative electrical clipping of body hair in the operative field lowers the risk of intraoperative contamination.
200 male participants, 18 years or older, with a planned primary knee replacement surgery, will be enrolled.
During surgery, four microbiological samples will be taken from each participant.
The primary outcome is whether there is intraoperative contamination of the surgical site or not, determined by identification of any grown bacteria from the samples.
If this study finds, that the contamination rate is lowered by preoperative electrical clipping of body hair, it will provide a cost-effective method of reducing the risk of intraoperative contamination and consequent postoperative infection, a solid argument for a change of current guidelines for preoperative hair removal, and provide additional information pointing towards body hair as a possible explanation for the increased infection rate in men.
详细描述
A late ph.d.-study conducted at Herlev and Gentofte Hospital has shown a 15 percentage difference in contamination rates when comparing participants who had their body hair removed preoperatively, and those who did not.
Based on the finds in the aforementioned study, the hypothesis for this study is that preoperative electrical clipping of body hair in the operative field lowers the risk of intraoperative contamination.
The purpose of this study is to investigate, whether preoperative electrical clipping of body hair affects the risk of intraoperative contamination.
A prospective, non-blinded, randomized controlled trial will be performed. The study population consists of 200 male patients, 18 years or older, with a planned primary knee replacement surgery. The study population consists of only male patients, since males generally have denser body hair and a higher contamination rate than females. Exclusion criteria include known skin disease, use of antibiotics 4 weeks prior to surgery, if patients due to mental reasons, a language barrier or other reasons are unable to participate in the study, as well as no body hair in the surgical field.
Participants will be randomized to either the intervention group (preoperative electrical clipping) or the control group (leaving the body hair intact) using a 1:1 randomization ratio. The randomization is performed electronically by a medical student or the operating surgeon and the pre-assessment consultation.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Planned primary knee replacement surgery
排除标准
- •Known skin disease
- •Use of antibiotics 4 weeks prior to surgery
- •If patients due to mental reasons, a language barrier or other reasons are unable to participate in the study
- •No body hair in the surgical field
结局指标
主要结局
Intraoperative contamination rate
时间窗: 1 year
Rate of contamination as amount of indentified bacteria cultured.
次要结局
未报告次要终点
研究者
Ditte Harder
Principal Investigator
Herlev and Gentofte Hospital