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

NCT03508492 | Unknown

• 1 other identifier: CA-IQZ
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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%

Conditions

Satisfaction; Product Quality

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

• Surgical site infection incidence

  During the first 30 to 90 days after surgery, according to the SSI prevention protocol

Study Arms (4)

Knee surgeons

ACTIVE COMPARATOR

Four knee surgeons

Other: Surgical tinted Chloraprep® applicators; Other: Surgical tinted Nex Clorex 2% applicators

Hip surgeons

ACTIVE COMPARATOR

Six hip surgeons

Other: Surgical tinted Chloraprep® applicators; Other: Surgical tinted Nex Clorex 2% applicators

Cardiac surgeons

ACTIVE COMPARATOR

6 cardiac surgeons

Other: Surgical tinted Chloraprep® applicators; Other: Surgical tinted Nex Clorex 2% applicators

Colon surgeons

ACTIVE COMPARATOR

6 colon surgeons

Other: Surgical tinted Chloraprep® applicators; Other: Surgical tinted Nex Clorex 2% applicators

Interventions

Surgical tinted Chloraprep® applicators OTHER

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.

Cardiac surgeons; Colon surgeons; Hip surgeons; Knee surgeons

Surgical tinted Nex Clorex 2% applicators OTHER

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.

Cardiac surgeons; Colon surgeons; Hip surgeons; Knee surgeons

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cristina Fernandez Perez: lead

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Cristina Fernandez Perez, Ph D.

CONTACT

+34913303430; cfernandezp@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Preventive and Public Health Department

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 25, 2018
• Study Start: April 1, 2018
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: April 25, 2018

Record last verified: 2018-04