Comparative Study to Asses the Satisfaction With Tinted Chlorhexidine Applicators (Chloraprep® and Nex Clorex 2%)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 22
- 主要终点
- Surgeon's global satisfaction with the applicators.
研究概览
简要总结
The development of surgical site infections (SSI) in clean-contaminated surgery is regarded as being preventable. Known to be effective in the prevention of surgical site infection are the adequate sterilization of the surgical instruments, asepsis during operation, antibiotic prophylaxis where indicated, and certainly the preparation of the skin at the incision site. During the last decades the use of alcoholic chlorhexidine has replaced povidone iodine for preoperative skin preparation. In order to improve the way alcoholic chlorhexidine is applied, pharmaceutical industry has developed new applicators.
This randomized study was conducted to know the surgeons' satisfaction within the use of two tinted applicators: Chloraprep® and Nex Clorex 2%
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteer surgeons from colon, cardiac, knee and hip surgical departments. Once surgeon has enrolled the study, patients will be selected if they have hospital admission with scheduled surgery and have signed informed consent
排除标准
- •Urgent surgeries
- •Outpatient surgery
- •Surgical complex cures
- •Mixed interventions: exploratory or sequential
- •Unscheduled surgeries
- •Rejection of participation
- •Chlorhexidine or isopropyl alcohol hypersensibility patients
- •If any patients changed its mind after signing the informed consent will be removed from the study.
研究组 & 干预措施
Knee surgeons
Four knee surgeons
干预措施: Surgical tinted Chloraprep® applicators (Other)
Knee surgeons
Four knee surgeons
干预措施: Surgical tinted Nex Clorex 2% applicators (Other)
Hip surgeons
Six hip surgeons
干预措施: Surgical tinted Chloraprep® applicators (Other)
Hip surgeons
Six hip surgeons
干预措施: Surgical tinted Nex Clorex 2% applicators (Other)
Cardiac surgeons
6 cardiac surgeons
干预措施: Surgical tinted Chloraprep® applicators (Other)
Cardiac surgeons
6 cardiac surgeons
干预措施: Surgical tinted Nex Clorex 2% applicators (Other)
Colon surgeons
6 colon surgeons
干预措施: Surgical tinted Chloraprep® applicators (Other)
Colon surgeons
6 colon surgeons
干预措施: Surgical tinted Nex Clorex 2% applicators (Other)
结局指标
主要结局
Surgeon's global satisfaction with the applicators.
时间窗: Intraoperative
Using an analog visual scale we will record the total score, over a maximum of 80 points, that assess the following quality aspects of the applicators: * Satisfaction with the presentation of the product * Satisfaction with the simplicity of activation * Satisfaction with the mix of the different components of the product * Satisfaction with the comfort of product use * Satisfaction with the surface covered by an applicator * Satisfaction with the shape of the applicator for painting areas of difficult access * Satisfaction with the drying time of the product * Satisfaction with the area delimited with the use of the product
Qualities of each applicators
时间窗: Intraoperative
Using an analog visual scale, were one end represents "totally disagree" and the other "totally agree" (0-10 points), we will record the score of each of the following quality aspects of the applicators: * Satisfaction with the presentation of the product * Satisfaction with the simplicity of activation * Satisfaction with the mix of the different components of the product * Satisfaction with the comfort of product use * Satisfaction with the surface covered by an applicator * Satisfaction with the shape of the applicator for painting areas of difficult access * Satisfaction with the drying time of the product * Satisfaction with the area delimited with the use of the product
次要结局
- Surgical site infection incidence(During the first 30 to 90 days after surgery, according to the SSI prevention protocol)
- Costs of using the applicators(Through study completion, an average of 3 months)
- Adhesion to preoperative measures to avoid surgical site infections (SSI)(Through study completion, an average of 3 months)
研究者
Cristina Fernandez Perez
Head of Preventive and Public Health Department
Hospital San Carlos, Madrid