3rd Level Intensive Care UnitNCT05614154
Comparison of the Efficacy of Antiseptics in Catheter Dressings
A study testing hypochlorous active substance in people with 3rd Level Intensive Care Unit, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Intensive care units (ICUs) are care centers where many different technological tools and equipment are used to support the highest level of life functions for patients with severe physical condition. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- 3rd Level Intensive Care Unit
- What is being tested?
- hypochlorous active substance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Nov 2022to 23 Feb 2023
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1- 18 years or older 2- Opening the central venous catheter in the intensive care unit 3- Verbal consent from the relatives of the patients to participate in the study is accepted to participate in the study.
- -
Who cannot join
- Being under the age of 18
- Exitus before the expected follow-up period of the patient
- Being pregnant
- Transferring from another unit or center to the Intensive Care Unit by CVC
- Patients with a previous diagnosis of LVMI-CDE
- Patients whose CVC was opened and CVC dressing was changed outside the control of the researcher -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy of Antiseptics With Povidone Iodine and Hypochlorous Acid Active Substance in Catheter Dressings in Preventing Central Catheter-Related Bloodstream Infection in Intensive Care Units
Intensive care units (ICUs) are care centers where many different technological tools and equipment are used to support the highest level of life functions for patients with severe physical condition. With the developing treatment and care methods, the use of more tools and equipment for invasive or non-invasive procedures has increased, however, complications related to the use of devices and the complications caused by them have also increased. Intensive care centers are centers where invasive procedures are frequently applied and instruments are used frequently, and central venous catheters (CVCs) are widely used, especially for patient-related reasons. CVCs have become one of the most important tools of intensive care units due to the different areas in which they are used and the benefits they provide.
Read the detailed description
1.625 / 5.000 Çeviri sonuçları star_border A CVC is a cannula placed in a venous vein that goes directly to the heart. 4 CVCs are used for frequent blood sampling, continuous Total Parenteral Nutrition (TPN) administration, blood and blood product transfusions, hemodialysis, long-term fluid replacements, drug treatments in cases where vascular access cannot be used due to long-term and intensive treatments. It is used for a variety of purposes, such as the delivery of inotropes.
In addition to the benefits they provide, CVCs also have many negative side effects. The most common complications are infection, thrombosis and bleeding. central venous catheter-associated bloodstream infections (LVMI-CDE); It is seen as an important problem related to the use of central venous catheters in health services in ICUs.
The day the CVC is placed is recorded as day 1. Laboratory-confirmed BSI can be placed on the 3rd day of the catheter at the earliest, and the day after the catheter removal at the latest.9 The most important step in the management of LVMI-BSI is the prevention of infection. In order to prevent these unavoidable infections, precautions should be taken and antiseptic rules should be followed during the placement, use and maintenance of CVCs. Nurses are responsible for catheter care, monitoring and reporting in case of complications. Therefore, the specific care given by nurses has an effect on other catheter-related complications and increased infection. Catheter dressings can be considered as risk factors for bloodstream infection. For this reason, the antiseptics used during the dressing are also important.
Hypochlorous acid (HOCl), another antiseptic, is a highly effective product that is frequently used in dressings and wound care in recent years. Hypochlorous acid is also a physiological molecule synthesized by neutrophil cells during phagocytosis and plays an active role in the destruction of all microorganisms.
It has been shown in studies that HOCl inactivates various viruses, including coronaviruses, in less than 1 minute. 26 It has been stated that the use of HOCl in eyelid inflammation reduces the rate of bacteria on the skin surface. Twenty minutes after application of a saline hygiene solution containing HOCl at 100 ppm, more than 99% reduction in staphylococcal load was reported.27 In a clinical study of intraperitoneal wound care, in a randomized controlled study with forty-four patients aged 3-14 years, 20 patients were lavaged with 100 ml/kg isotonic into the peritoneal cavity and the wound was washed with 200 ml of isotonic, and 26 patients were poured 100 ml/kg into the peritoneal cavity. Lavage was done with HOCl and the wound was washed with 200 ml of HOCl. It was stated that no side effects were observed. HOCl is extremely ecological because its breakdown produces only brine and traces of chloride gas. It is economical as its source is only unsterilized tap water and salt.28 In a study examining the effect of stabilized hypochlorous acid solution (HOCl) on the killing rate, biofilm formation, antimicrobial activity in the biofilm on frequently isolated microorganisms and the migration rate of injured fibroblasts and keratinocytes, all microorganisms were killed within 0 minutes and the exact killing time was stated to be 12 seconds. The stabilized HOCl solution had dose-dependent positive effects on fibroblast and keratinocyte migration compared to povidone-iodine and medium alone. It was stated that it can be used as an ideal wound care agent.
In a study on diabetic foot wound, povidone iodine was compared with HOCl. The duration of antibiotic use decreased in cases where HOCl acid was used compared to povidone iodine. In the studies, in soft tissue and bone tissue; It has been shown to reduce inflammation and accelerate wound healing. Topically stabilized HOCl provides an optimal wound healing environment and when combined with silicone can be ideal for reducing scarring. Used as an antiseptic skin preparation, HOCl poses no concerns of ocular or ototoxicity. The fact that it is cheaper than other antiseptic solutions for dressings and is effective in many bacterial infections without damaging the tissue may cause more frequent use of hypochlorous acid. This study is extremely important in terms of providing evidence to the literature. Studies have shown that as a result of the correct nursing care and dressings made with the correct products, the rate of bloodstream infections, mortality and morbidity, as well as hospital costs due to the catheter, are greatly reduced. In this study, it was aimed to compare the effectiveness of antiseptics containing chlorhexidine, povidone iodine and hypochlorous acid active ingredient in catheter dressings in preventing central catheter-related bloodstream infection in intensive care units.
- Conditions
- 3rd Level Intensive Care Unit
- Being tested
- hypochlorous active substance
- Keywords
- central venous catheter, infection
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypochlorous active substanceOther
Poviodin iyot
| Study group | Role | What they receive |
|---|---|---|
| Povidone-iodine Group | Active comparator | The care of patients with central venous catheters will be done with Povidone iodine as long as they stay in the intensive care unit Receives: Other: hypochlorous active substance |
| hypochlorous active substance | Experimental | The care of patients with central venous catheters will be done with antiseptic with hypochlorous active substance as long as they stay in the intensive care unit. Receives: Other: hypochlorous active substance |
What is being measured
The primary outcome is the main question the study is designed to answer.
infection and viral signs tracking form
presence of infection in the central venous catheter site, if any, redness, temperature increase and presence of exudate around the catheter exit site, blood culture sampling date, body temperature/chills, number of blood cultures, microorganism name, vital signs (pulse, blood pressure, saturation, respiratory number) is included. Two blood cultures, peripheral and catheter, are taken as soon as the patient is placed in the catheter. In addition, if the patient has fever (> 38 °C), hypotension (systolic blood pressure < 90 mmHg) or oliguria (< 20 mL/hour) without any reason, and there is redness, swelling or purulent discharge around the catheter, the catheter blood culture is renewed.
Measured: 4 times in 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start4 Nov 2022
- Primary completion4 Feb 2023
- Study completion23 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 3rd Level Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients meeting the inclusion criteria Patients dressed with 1st group Povidone-iodine antiseptic (routinely applied antiseptic in the clinic)
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vesile Eskici Ilgin, Ataturk University
- Investigators
- Vesile eskici İlgin, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614154
- Sponsor's protocol ID
- Vesile30
- Status last verified
- Jun 2023
- First submitted
- 5 Nov 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Antiseptics With Povidone Iodine and Hypochlorous Acid Active Substance in Catheter Dressings in Preventing Central Catheter-Related Bloodstream Infection in Intensive Care Units
- ClinicalTrials.gov ID
- NCT05614154
- Acronym / sponsor ID
- Vesile30
- Conditions
- 3rd Level Intensive Care Unit
- Keywords
- central venous catheter, infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 4 Feb 2023 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 14 Nov 2022 (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.
Intensive care units (ICUs) are care centers where many different technological tools and equipment are used to support the highest level of life functions for patients with severe physical condition. With the developing treatment and care methods, the use of more tools and equipment for invasive or non-invasive procedures has increased, however, complications related to the use of devices and the complications caused by them have also increased. Intensive care centers are centers where invasive procedures are frequently applied and instruments are used frequently, and central venous catheters (CVCs) are widely used, especially for patient-related reasons. CVCs have become one of the most important tools of intensive care units due to the different areas in which they are used and the benefits they provide.
Detailed description
1.625 / 5.000 Çeviri sonuçları star_border A CVC is a cannula placed in a venous vein that goes directly to the heart. 4 CVCs are used for frequent blood sampling, continuous Total Parenteral Nutrition (TPN) administration, blood and blood product transfusions, hemodialysis, long-term fluid replacements, drug treatments in cases where vascular access cannot be used due to long-term and intensive treatments. It is used for a variety of purposes, such as the delivery of inotropes.
In addition to the benefits they provide, CVCs also have many negative side effects. The most common complications are infection, thrombosis and bleeding. central venous catheter-associated bloodstream infections (LVMI-CDE); It is seen as an important problem related to the use of central venous catheters in health services in ICUs.
The day the CVC is placed is recorded as day 1. Laboratory-confirmed BSI can be placed on the 3rd day of the catheter at the earliest, and the day after the catheter removal at the latest.9 The most important step in the management of LVMI-BSI is the prevention of infection. In order to prevent these unavoidable infections, precautions should be taken and antiseptic rules should be followed during the placement, use and maintenance of CVCs. Nurses are responsible for catheter care, monitoring and reporting in case of complications. Therefore, the specific care given by nurses has an effect on other catheter-related complications and increased infection. Catheter dressings can be considered as risk factors for bloodstream infection. For this reason, the antiseptics used during the dressing are also important.
Hypochlorous acid (HOCl), another antiseptic, is a highly effective product that is frequently used in dressings and wound care in recent years. Hypochlorous acid is also a physiological molecule synthesized by neutrophil cells during phagocytosis and plays an active role in the destruction of all microorganisms.
It has been shown in studies that HOCl inactivates various viruses, including coronaviruses, in less than 1 minute. 26 It has been stated that the use of HOCl in eyelid inflammation reduces the rate of bacteria on the skin surface. Twenty minutes after application of a saline hygiene solution containing HOCl at 100 ppm, more than 99% reduction in staphylococcal load was reported.27 In a clinical study of intraperitoneal wound care, in a randomized controlled study with forty-four patients aged 3-14 years, 20 patients were lavaged with 100 ml/kg isotonic into the peritoneal cavity and the wound was washed with 200 ml of isotonic, and 26 patients were poured 100 ml/kg into the peritoneal cavity. Lavage was done with HOCl and the wound was washed with 200 ml of HOCl. It was stated that no side effects were observed. HOCl is extremely ecological because its breakdown produces only brine and traces of chloride gas. It is economical as its source is only unsterilized tap water and salt.28 In a study examining the effect of stabilized hypochlorous acid solution (HOCl) on the killing rate, biofilm formation, antimicrobial activity in the biofilm on frequently isolated microorganisms and the migration rate of injured fibroblasts and keratinocytes, all microorganisms were killed within 0 minutes and the exact killing time was stated to be 12 seconds. The stabilized HOCl solution had dose-dependent positive effects on fibroblast and keratinocyte migration compared to povidone-iodine and medium alone. It was stated that it can be used as an ideal wound care agent.
In a study on diabetic foot wound, povidone iodine was compared with HOCl. The duration of antibiotic use decreased in cases where HOCl acid was used compared to povidone iodine. In the studies, in soft tissue and bone tissue; It has been shown to reduce inflammation and accelerate wound healing. Topically stabilized HOCl provides an optimal wound healing environment and when combined with silicone can be ideal for reducing scarring. Used as an antiseptic skin preparation, HOCl poses no concerns of ocular or ototoxicity. The fact that it is cheaper than other antiseptic solutions for dressings and is effective in many bacterial infections without damaging the tissue may cause more frequent use of hypochlorous acid. This study is extremely important in terms of providing evidence to the literature. Studies have shown that as a result of the correct nursing care and dressings made with the correct products, the rate of bloodstream infections, mortality and morbidity, as well as hospital costs due to the catheter, are greatly reduced. In this study, it was aimed to compare the effectiveness of antiseptics containing chlorhexidine, povidone iodine and hypochlorous acid active ingredient in catheter dressings in preventing central catheter-related bloodstream infection in intensive care units.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients meeting the inclusion criteria Patients dressed with 1st group Povidone-iodine antiseptic (routinely applied antiseptic in the clinic)
| Arm | Type | Receives |
|---|---|---|
| Povidone-iodine Group | Active comparator | Other: hypochlorous active substanceThe care of patients with central venous catheters will be done with Povidone iodine as long as they stay in the intensive care unit |
| hypochlorous active substance | Experimental | Other: hypochlorous active substanceThe care of patients with central venous catheters will be done with antiseptic with hypochlorous active substance as long as they stay in the intensive care unit. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1- 18 years or older 2- Opening the central venous catheter in the intensive care unit 3- Verbal consent from the relatives of the patients to participate in the study is accepted to participate in the study.
- -
Key exclusion criteria (6 listed)
- Being under the age of 18
- Exitus before the expected follow-up period of the patient
- Being pregnant
- Transferring from another unit or center to the Intensive Care Unit by CVC
- Patients with a previous diagnosis of LVMI-CDE
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 |
|---|---|---|
| hypochlorous active substancePoviodin iyot | Other | Povidone-iodine Group, hypochlorous active substance |
Primary outcome
infection and viral signs tracking form
Time frame: 4 times in 24 hours
presence of infection in the central venous catheter site, if any, redness, temperature increase and presence of exudate around the catheter exit site, blood culture sampling date, body temperature/chills, number of blood cultures, microorganism name, vital signs (pulse, blood pressure, saturation, respiratory number) is included. Two blood cultures, peripheral and catheter, are taken as soon as the patient is placed in the catheter. In addition, if the patient has fever (> 38 °C), hypotension (systolic blood pressure < 90 mmHg) or oliguria (< 20 mL/hour) without any reason, and there is redness, swelling or purulent discharge around the catheter, the catheter blood culture is renewed.
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 Jun 2023.
- Individual participant dataSharing planned: No
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.
Vesile eskici İlgin principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypochlorous active substance in people with 3rd Level Intensive Care Unit, run by Ataturk University at 1 site in Turkey (Türkiye).
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 2 inclusion and 6 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 Jun 2023. 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 Turkey (Türkiye). 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.
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?
infection and viral signs tracking form (time frame: 4 times in 24 hours). 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 Jun 2023.