Comparison of the Efficacy of Antiseptics in Catheter Dressings

June 20, 2023 updated by: Vesile Eskici Ilgin, Ataturk University

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

52

Phase

  • 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 Locations

      • Erzurum, Turkey
        • Atatürk University

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

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

-

Exclusion Criteria:

  1. Being under the age of 18
  2. Exitus before the expected follow-up period of the patient
  3. Being pregnant
  4. Transferring from another unit or center to the Intensive Care Unit by CVC
  5. Patients with a previous diagnosis of LVMI-CDE
  6. Patients whose CVC was opened and CVC dressing was changed outside the control of the researcher -

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: 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
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

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Vesile eskici İlgin, Atatürk University

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 (Actual)

November 4, 2022

Primary Completion (Actual)

February 4, 2023

Study Completion (Actual)

February 23, 2023

Study Registration Dates

First Submitted

November 5, 2022

First Submitted That Met QC Criteria

November 5, 2022

First Posted (Actual)

November 14, 2022

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Vesile30

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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