Skin Disinfection Before Peripheral Venous Catheter InsertionPhase 4DACLEANNCT04391660
Estimation of the Incidence of Colonization of Peripheral Venous Catheters After Skin Disinfection With 0.5% Sodium Hypochlorite, Preceded or Not by an Application of 70% Ethanol
A Phase 4 study testing 0.5% sodium hypochlorite solution and 0.5% sodium hypochlorite solution and 70% ethanol in people with Skin Disinfection Before Peripheral Venous Catheter Insertion, run by Poitiers University Hospital at 1 site in France.
Trial summary
The peripheral venous catheter is the most commonly used medical device in the hospital setting. Infectious complications are infrequent, bacterial or fungal, and local or systemic (catheter-related bacteremia). The latter prolong the length of hospitalization and increase the cost of care and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Disinfection Before Peripheral Venous Catheter Insertion
- What is being tested?
- 0.5% sodium hypochlorite solution and 0.5% sodium hypochlorite solution and 70% ethanol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2020to 8 Jan 2021
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient (≥18 years old) requiring hospitalization in participating services
- Having an indication for the placement of a peripheral venous catheter for an expected duration of at least 48 hours
- Free subject, without guardianship or curatorship or subordination
- A person affiliated to or benefiting from a social security scheme.
- Having given free and informed consent
Who cannot join
- Hypersensitivity to any of the constituents of Dakin® and/or Cooper® modified alcohol;
- History of epilepsy,
- Placement of a peripheral venous catheter in the emergency room that does not allow the usual rules of hygiene to be respected;
- Difficult vascular access foreseeable (drug addict, obese, non-visible veins...);
- Participation in another research protocol reducing the risk of catheter-related infection;
- Patient having received an antibiotic treatment in the 15 days prior to inclusion in the study;
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- Patient who has already participated in the study;
- Subjects not affiliated with a Social Security system.
- Subjects benefiting from enhanced protection, namely persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection (guardianship and trusteeship) and finally patients in emergency situations.
- Pregnant or breastfeeding women, women of child-bearing age who do not have effective contraception (hormonal/mechanical: per os, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy...).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estimation of the Incidence of Colonization of Peripheral Venous Catheters After Skin Disinfection With 0.5% Sodium Hypochlorite, Preceded or Not by an Application of 70% Ethanol: Pilot, Monocentric, Randomized, Open-label Study
The peripheral venous catheter is the most commonly used medical device in the hospital setting. Infectious complications are infrequent, bacterial or fungal, and local or systemic (catheter-related bacteremia). The latter prolong the length of hospitalization and increase the cost of care and mortality. For peripheral venous catheters, the risk of catheter-related bacteremia is lower (0.2-0.7 episodes per 1000 catheter days) than for other intravascular devices. However, the much higher number of peripheral venous catheters used explains a total number of infections close to that of other catheters. Colonization is usually the preliminary step to catheter infection. It is far more common than infection. Skin disinfection prior to catheter insertion is therefore essential to prevent this complication.
Currently, Chlorhexidine or Povidone Iodine in alcoholic solution is recommended before insertion of a peripheral venous catheter. Although rare, allergies may contraindicate these antiseptics. The widespread use of antiseptics in recent years for hand disinfection, mouthwashes or body baths could increase the risk of the development of strains that have become less sensitive, or even resistant, to currently available antiseptics. Allergies and reduced sensitivity require the search for alternatives to currently available solutions. Sodium hypochlorite is used to disinfect mucous membranes or healthy skin before an invasive procedure in children under 30 months of age. Very few studies have evaluated its efficacy in adults for this same indication, despite the fact that it was the first antiseptic used to prevent infections.
The aim of this study is to estimate the colonization rate of peripheral venous catheters after skin disinfection with 0.5% sodium hypochlorite (Dakin®) alone or preceded by an application of 70% ethanol.
- Being tested
- 0.5% sodium hypochlorite solution, 0.5% sodium hypochlorite solution and 70% ethanol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5% sodium hypochlorite solutionDrug
Disinfection with a 0.5% sodium hypochlorite solution applied with a sterile compress. This same antiseptic will be used at each dressing change.
0.5% sodium hypochlorite solution and 70% ethanolDrug
Disinfection with a 0.5% sodium hypochlorite solution applied with a sterile compress preceded by an application of 70% ethanol with a sterile compress, for its immediate bactericidal action. 0.5% sodium hypochlorite solution will be applied once the alcohol has evaporated and the skin is visually dried. These same antiseptics will be used at each dressing change.
| Study group | Role | What they receive |
|---|---|---|
| 0.5% sodium hypochlorite solution | Active comparator | Not described Receives: Drug: 0.5% sodium hypochlorite solution |
| 0.5% sodium hypochlorite solution and 70% ethanol | Active comparator | Not described Receives: Drug: 0.5% sodium hypochlorite solution and 70% ethanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of colonized catheters
Measured: Up to 14 days
Secondary outcomes (5)
Local infection, defined as colonization of the catheter or purulent discharge at the insertion site with a positive culture or no culture at the insertion site (a negative culture, in the absence of antibiotics, eliminates the case)
Measured: Up to 14 days
General infection, defined as colonization of the catheter in the presence of general signs of infection and total or partial regression of these signs within 48 hours after catheter removal
General infection, defined as colonization of the catheter in the presence of general signs of infection (fever > 38.5° or hypothermia < 36°, chills, hypotension with PAS < 90 mmHg) and total or partial regression of these signs within 48 hours after catheter removal
Measured: Up to 16 days
Catheter-related bacteremia/fungemia
Measured: Up to 14 days
Incidence of a positive catheter culture regardless of the threshold and the microorganism under consideration
Measured: Up to 14 days
Incidence of local skin reaction and its severity
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start15 Jun 2020
- Primary completion8 Jan 2021
- Study completion8 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Disinfection Before Peripheral Venous Catheter InsertionStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391660
- Sponsor's protocol ID
- DACLEAN
- Acronym
- DACLEAN
- Status last verified
- May 2020
- First submitted
- 6 May 2020
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of the Incidence of Colonization of Peripheral Venous Catheters After Skin Disinfection With 0.5% Sodium Hypochlorite, Preceded or Not by an Application of 70% Ethanol: Pilot, Monocentric, Randomized, Open-label Study
- ClinicalTrials.gov ID
- NCT04391660
- Acronym / sponsor ID
- DACLEAN / DACLEAN
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 8 Jan 2021 (actual)
- Study completion
- 8 Jan 2021 (actual)
- First posted
- 18 May 2020 (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 peripheral venous catheter is the most commonly used medical device in the hospital setting. Infectious complications are infrequent, bacterial or fungal, and local or systemic (catheter-related bacteremia). The latter prolong the length of hospitalization and increase the cost of care and mortality. For peripheral venous catheters, the risk of catheter-related bacteremia is lower (0.2-0.7 episodes per 1000 catheter days) than for other intravascular devices. However, the much higher number of peripheral venous catheters used explains a total number of infections close to that of other catheters. Colonization is usually the preliminary step to catheter infection. It is far more common than infection. Skin disinfection prior to catheter insertion is therefore essential to prevent this complication.
Currently, Chlorhexidine or Povidone Iodine in alcoholic solution is recommended before insertion of a peripheral venous catheter. Although rare, allergies may contraindicate these antiseptics. The widespread use of antiseptics in recent years for hand disinfection, mouthwashes or body baths could increase the risk of the development of strains that have become less sensitive, or even resistant, to currently available antiseptics. Allergies and reduced sensitivity require the search for alternatives to currently available solutions. Sodium hypochlorite is used to disinfect mucous membranes or healthy skin before an invasive procedure in children under 30 months of age. Very few studies have evaluated its efficacy in adults for this same indication, despite the fact that it was the first antiseptic used to prevent infections.
The aim of this study is to estimate the colonization rate of peripheral venous catheters after skin disinfection with 0.5% sodium hypochlorite (Dakin®) alone or preceded by an application of 70% ethanol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.5% sodium hypochlorite solution | Active comparator | Drug: 0.5% sodium hypochlorite solution |
| 0.5% sodium hypochlorite solution and 70% ethanol | Active comparator | Drug: 0.5% sodium hypochlorite solution and 70% ethanol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patient (≥18 years old) requiring hospitalization in participating services
- Having an indication for the placement of a peripheral venous catheter for an expected duration of at least 48 hours
- Free subject, without guardianship or curatorship or subordination
- A person affiliated to or benefiting from a social security scheme.
- Having given free and informed consent
Key exclusion criteria (10 listed)
- Hypersensitivity to any of the constituents of Dakin® and/or Cooper® modified alcohol;
- History of epilepsy,
- Placement of a peripheral venous catheter in the emergency room that does not allow the usual rules of hygiene to be respected;
- Difficult vascular access foreseeable (drug addict, obese, non-visible veins...);
- Participation in another research protocol reducing the risk of catheter-related infection;
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 |
|---|---|---|
| 0.5% sodium hypochlorite solutionDisinfection with a 0.5% sodium hypochlorite solution applied with a sterile compress. This same antiseptic will be used at each dressing change. | Drug | 0.5% sodium hypochlorite solution |
| 0.5% sodium hypochlorite solution and 70% ethanolDisinfection with a 0.5% sodium hypochlorite solution applied with a sterile compress preceded by an application of 70% ethanol with a sterile compress, for its immediate bactericidal action. 0.5% sodium hypochlorite solution will be applied once the alcohol has evaporated and the skin is visually dried. These same antiseptics will be used at each dressing change. | Drug | 0.5% sodium hypochlorite solution and 70% ethanol |
Primary outcome
Incidence of colonized catheters
Time frame: Up to 14 days
5 secondary outcomes
Local infection, defined as colonization of the catheter or purulent discharge at the insertion site with a positive culture or no culture at the insertion site (a negative culture, in the absence of antibiotics, eliminates the case)
Time frame: Up to 14 days
General infection, defined as colonization of the catheter in the presence of general signs of infection and total or partial regression of these signs within 48 hours after catheter removal
Time frame: Up to 16 days
Catheter-related bacteremia/fungemia
Time frame: Up to 14 days
Incidence of a positive catheter culture regardless of the threshold and the microorganism under consideration
Time frame: Up to 14 days
Incidence of local skin reaction and its severity
Time frame: Up to 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.5% sodium hypochlorite solution and 0.5% sodium hypochlorite solution and 70% ethanol in people with Skin Disinfection Before Peripheral Venous Catheter Insertion, run by Poitiers University Hospital at 1 site in France.
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 5 inclusion and 10 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: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of colonized catheters (time frame: Up to 14 days). 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 22 Jan 2021.