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

April 24, 2018 updated by: Cristina Fernandez Perez

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Surgeon's global satisfaction with the applicators.
Time Frame: 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 product
Intraoperative
Qualities of each applicators
Time Frame: 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
Intraoperative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Costs of using the applicators
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
Adhesion to preoperative measures to avoid surgical site infections (SSI)
Time Frame: 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
Through study completion, an average of 3 months
Surgical site infection incidence
Time Frame: During the first 30 to 90 days after surgery, according to the SSI prevention protocol
During the first 30 to 90 days after surgery, according to the SSI prevention protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cristina Fernandez Perez

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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