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

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

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%

Study Overview

• Status: Unknown
• Conditions: Satisfaction; Product Quality
• Intervention / Treatment: Other: Surgical tinted Chloraprep® applicators; Other: Surgical tinted Nex Clorex 2% applicators

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Knee surgeons; Four knee surgeons	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.; Other: 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.
Active Comparator: Hip surgeons; Six hip surgeons	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.; Other: 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.
Active Comparator: Cardiac surgeons; 6 cardiac surgeons	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.; Other: 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.
Active Comparator: Colon surgeons; 6 colon surgeons	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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Costs of using the applicators		Through study completion, an average of 3 months
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
Surgical site infection incidence		During the first 30 to 90 days after surgery, according to the SSI prevention protocol

Collaborators and Investigators

• Sponsor: Cristina Fernandez Perez

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2018
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: April 5, 2018
• First Submitted That Met QC Criteria: April 24, 2018
• First Posted (Actual): April 25, 2018

Study Record Updates

• Last Update Posted (Actual): April 25, 2018
• Last Update Submitted That Met QC Criteria: April 24, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: CA-IQZ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No