SatisfactionNCT03508492
Surgeons' Satisfaction With Two Types of Tinted Chlorhexidine Applicators (Chloraprep® and Nex Clorex 2%)
A study testing Surgical tinted Chloraprep® applicators and Surgical tinted Nex Clorex 2% applicators in people with Satisfaction and Product Quality, run by Cristina Fernandez Perez.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Satisfaction, Product Quality
- What is being tested?
- Surgical tinted Chloraprep® applicators and Surgical tinted Nex Clorex 2% applicators
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Apr 2018to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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%
- Conditions
- Satisfaction, Product Quality
- Being tested
- Surgical tinted Chloraprep® applicators, Surgical tinted Nex Clorex 2% applicators
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical tinted Chloraprep® applicatorsOther
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% applicatorsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Knee surgeons | Active comparator | Four knee surgeons Receives: Other: Surgical tinted Chloraprep® applicators; Other: Surgical tinted Nex Clorex 2% applicators |
| Hip surgeons | Active comparator | Six hip surgeons Receives: Other: Surgical tinted Chloraprep® applicators; Other: Surgical tinted Nex Clorex 2% applicators |
| Cardiac surgeons | Active comparator | 6 cardiac surgeons Receives: Other: Surgical tinted Chloraprep® applicators; Other: Surgical tinted Nex Clorex 2% applicators |
| Colon surgeons | Active comparator | 6 colon surgeons Receives: Other: Surgical tinted Chloraprep® applicators; Other: Surgical tinted Nex Clorex 2% applicators |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Intraoperative
Secondary outcomes (3)
Costs of using the applicators
Measured: 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
Measured: Through study completion, an average of 3 months
Surgical site infection incidence
Measured: During the first 30 to 90 days after surgery, according to the SSI prevention protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study startApr 2018 (estimated)
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SatisfactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cristina Fernandez Perez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cristina Fernandez Perez, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508492
- Sponsor's protocol ID
- CA-IQZ
- Status last verified
- Apr 2018
- First submitted
- 5 Apr 2018
- Last updated
- 25 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study to Asses the Satisfaction With Tinted Chlorhexidine Applicators (Chloraprep® and Nex Clorex 2%)
- ClinicalTrials.gov ID
- NCT03508492
- Acronym / sponsor ID
- CA-IQZ
- Conditions
- Satisfaction, Product Quality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cristina Fernandez PerezUniversity, hospital or other
- Study start
- Apr 2018 (estimated)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 25 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Knee surgeons | Active comparator | Other: Surgical tinted Chloraprep® applicators, Other: Surgical tinted Nex Clorex 2% applicatorsFour knee surgeons |
| Hip surgeons | Active comparator | Other: Surgical tinted Chloraprep® applicators, Other: Surgical tinted Nex Clorex 2% applicatorsSix hip surgeons |
| Cardiac surgeons | Active comparator | Other: Surgical tinted Chloraprep® applicators, Other: Surgical tinted Nex Clorex 2% applicators6 cardiac surgeons |
| Colon surgeons | Active comparator | Other: Surgical tinted Chloraprep® applicators, Other: Surgical tinted Nex Clorex 2% applicators6 colon surgeons |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- Urgent surgeries
- Outpatient surgery
- Surgical complex cures
- Mixed interventions: exploratory or sequential
- Unscheduled surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical tinted Chloraprep® applicatorsWe 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 | Cardiac surgeons, Colon surgeons, Hip surgeons, Knee surgeons |
| Surgical tinted Nex Clorex 2% applicatorsWe 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 | Cardiac surgeons, Colon surgeons, Hip surgeons, Knee surgeons |
Primary outcome
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
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
3 secondary outcomes
Costs of using the applicators
Time frame: 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
Surgical site infection incidence
Time frame: During the first 30 to 90 days after surgery, according to the SSI prevention protocol
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical tinted Chloraprep® applicators and Surgical tinted Nex Clorex 2% applicators in people with Satisfaction and Product Quality, run by Cristina Fernandez Perez.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristina Fernandez Perez, Ph D. (+34913303430, cfernandezp@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgeon's global satisfaction with the applicators. (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2018.