Surgeons' Satisfaction With Two Types of Tinted Chlorhexidine Applicators (Chloraprep® and Nex Clorex 2%)
- Conditions
- SatisfactionProduct Quality
- Interventions
- Other: Surgical tinted Chloraprep® applicatorsOther: Surgical tinted Nex Clorex 2% applicators
- Registration Number
- NCT03508492
- Lead Sponsor
- Cristina Fernandez Perez
- Brief Summary
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%
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 22
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Knee surgeons Surgical tinted Chloraprep® applicators Four knee surgeons Hip surgeons Surgical tinted Chloraprep® applicators Six hip surgeons Cardiac surgeons Surgical tinted Chloraprep® applicators 6 cardiac surgeons Knee surgeons Surgical tinted Nex Clorex 2% applicators Four knee surgeons Hip surgeons Surgical tinted Nex Clorex 2% applicators Six hip surgeons Colon surgeons Surgical tinted Chloraprep® applicators 6 colon surgeons Cardiac surgeons Surgical tinted Nex Clorex 2% applicators 6 cardiac surgeons Colon surgeons Surgical tinted Nex Clorex 2% applicators 6 colon surgeons
- Primary Outcome Measures
Name Time Method Surgeon's global satisfaction with the applicators. 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 productQualities of each applicators 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
- Secondary Outcome Measures
Name Time Method 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 Analyze the verification check list for surgical site infection preoperative prevention. This check list has been provided by the Preventive Medicine, Public Health and Hygiene Spanish Society as part of the Zero Surgical Site Infection Protocol.
This verification check list includes indicators of:
* Antibiotic prophylaxis
* Intraoperative Alcoholic Chlorhexidine application
* Hair removal from the surgical site
* Normotherapy
* Glycemic control