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

NCT ID: NCT03508492

Last Updated: 2018-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-30
• Study Completion Date: 2018-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Knee surgeons

Four knee surgeons

Group Type: ACTIVE_COMPARATOR

Surgical tinted Chloraprep® applicators

Intervention Type: 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.

Surgical tinted Nex Clorex 2% applicators

Intervention Type: 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.

Hip surgeons

Six hip surgeons

Group Type: ACTIVE_COMPARATOR

Surgical tinted Chloraprep® applicators

Intervention Type: 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.

Surgical tinted Nex Clorex 2% applicators

Intervention Type: 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

6 cardiac surgeons

Group Type: ACTIVE_COMPARATOR

Surgical tinted Chloraprep® applicators

Intervention Type: 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.

Surgical tinted Nex Clorex 2% applicators

Intervention Type: 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.

Colon surgeons

6 colon surgeons

Group Type: ACTIVE_COMPARATOR

Surgical tinted Chloraprep® applicators

Intervention Type: 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.

Surgical tinted Nex Clorex 2% applicators

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cristina Fernandez Perez

OTHER

Sponsor Role: lead

Responsible Party

Cristina Fernandez Perez

Head of Preventive and Public Health Department

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Cristina Fernandez Perez, Ph D.

Role: CONTACT

cfernandezp@salud.madrid.org

+34913303430

Other Identifiers

CA-IQZ

Identifier Type: -

Identifier Source: org_study_id