- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05614154
Comparison of the Efficacy of Antiseptics in Catheter Dressings
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Erzurum, Turkey
- Atatürk University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
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Exclusion Criteria:
- 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 -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Povidone-iodine Group
The care of patients with central venous catheters will be done with Povidone iodine as long as they stay in the intensive care unit
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Poviodin iyot
|
|
Experimental: hypochlorous active substance
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.
|
Poviodin iyot
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4 times in 24 hours
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vesile eskici İlgin, Atatürk University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Vesile30
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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