Surgeons' Satisfaction With Two Types of Tinted Chlorhexidine Applicators (Chloraprep® and Nex Clorex 2%)

Satisfaction Clinical Trial

Official title:

Comparative Study to Asses the Satisfaction With Tinted Chlorhexidine Applicators (Chloraprep® and Nex Clorex 2%)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03508492
• Other study ID #: CA-IQZ
• Status: Not yet recruiting
• Phase: N/A
• First received: April 5, 2018
• Last updated: April 24, 2018
• Start date: April 2018
• Est. completion date: June 2018

Study information

• Verified date: April 2018
• Source: Hospital San Carlos, Madrid
• Contact: Cristina Fernandez Perez, Ph D.
• Phone: +34913303430
• Email: cfernandezp[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Product Quality
• Satisfaction

Intervention

Other:
• Surgical tinted Chloraprep® applicators
We randomized knee, hip, cardiac and colon surgeons making them using two applicators of each brand in four of theirs surgeries. Randomization will be carried out in blocks of four for each surgeon.
• Surgical tinted Nex Clorex 2% applicators
We randomized knee, hip, cardiac and colon surgeons making them using two applicators of each brand in four of theirs surgeries. Randomization will be carried out in blocks of four for each surgeon.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cristina Fernandez Perez

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgeon's global satisfaction with the applicators.	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	Intraoperative
Primary	Qualities of each applicators	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	Intraoperative
Secondary	Costs of using the applicators		Through study completion, an average of 3 months
Secondary	Adhesion to preoperative measures to avoid surgical site infections (SSI)	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	Through study completion, an average of 3 months
Secondary	Surgical site infection incidence		During the first 30 to 90 days after surgery, according to the SSI prevention protocol