Effect of Chlorhexidine Solution in Preventing Peripheral Venous Catheter Associated-Infection

January 30, 2024 updated by: Nihal Taskiran, Aydin Adnan Menderes University

Effects of Chlorhexidine Solutions With Different Concentrations in Preventing Peripheral Venous Catheter-Associated Infections

This research aims to determine the most effective chlorhexidine concentration to be used in preventing peripheral venous catheter-associated infections. This research is a randomized controlled double-blinded experimental design. This research will conduct between July 2022-June 2023 with 96 intensive care patients at a state hospital in Turkey. The study sample consist of 96 new insertions of peripheral venous catheters.The study will carried out as a experimental trial to compare the efficacy 1%, 2% and 4% clorhexidine gluconate and 70% alcohol in preventing infections due to catheter administrations in patients. Patients who fulfilled the inclusion criteria is randomized according to the randomization programme into three experimental groups and the control group. "Patient Information Form", "Catheter Information Form" and "Observational Form" will used to collect data.The vital findings and local infection findings of the patients that peripheral venous catheter is inserted will followed and recorded at pre-insertion and once every 24 hours for 96 hours. Culture analyze will performed from swab example taken from catheter entry location at pre-insertion,1st hour and pre removal of catheter.Data will analyzed in statistical program and p<0,05 will considered as significant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This research is a randomized controlled double-blinded experimental design. The aim of the study is to determine the most effective chlorhexidine concentration to be used in preventing peripheral venous catheter-associated infections.The study will conducted between July 2022-June 2023 at the anaesthesia and reanimation intensive care unit of a government hospital. Sample size was assessed using G-power analysis (effect size 0.3; medium level α = 0.05; 1-β = 0.80), and it was found that for each group, 24 patients had the capability of representing the population.Patients were assigned to groups using the programme random number generator.Patients who fulfilled the criteria for inclusion will taken into the study as the experimental groups (group 1: 1% chlorhexidine; group 2: 2% chlorhexidine; group 3: 4% chlorhexidine) and the control group (group 4: 70% iso-propyl alcohol).The population of the study consisted of the patients in the intensive care unit of anaesthesia and the sample consisted of the 96 adult patients who will admitted to the intensive care unit within the dates when the study was conducted and who will insertioned peripheral venous catheter and remained inpatients for at least 4 days."Patient Information Form", "Catheter Information Form" and "Observational Form" will used to collect data. The "Patient Information Form" is consisting of 13 questions about the socio-demographic information about the patient, the "Catheter Information Form" is consisting of 13 questions about the information of the catheterization, and the "Observation Form" is consisting of 13 questions about the vital findings and local infection findings of the patients. The vital findings and local infection findings of the patients that peripheral venous catheter is inserted will followed and recorded at pre-insertion and once every 24 hours for 4 days. Culture analyze will performed from swab example taken from catheter entry location at pre-insertion,1st hour and pre removal of catheter.

To perform the statistical analysis for the study, the authors will utilized the Statistical Package for Social Science (SPSS 22.0) software program. The descriptive statistics will provided in a number and percentage format. According to the Kolmogorov-Smirnov test results, key variables of the present study will analyzed using the Mann-Whitney U test for binary groups and the Kruskal-Wallis test for triple groups.and p<0,05 will considered as significant.

Study Type

Interventional

Enrollment (Actual)

96

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

  • Turkey
    • Nazi̇lli̇
      • Aydin, Nazi̇lli̇, Turkey, 09800
        • TR Ministry of Health Nazilli State Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be over 18 years of age
  • Being inpatient in the Anesthesia and Reanimation Intensive Care Unit of the hospital where the research was conducted
  • No history of infection,
  • No history of catheter-related infection
  • No history of immunological disease
  • Being an indication for peripheral venous catheter intervention

Exclusion Criteria:

  • Having a central venous catheter inserted
  • Having a history of allergies
  • Having a history of chronic skin disease
  • Peripheral venous catheter is not suitable for intervention (scar tissue in the area to be operated, wound, burn, phlebitis, infiltration, extravasation, redness, discoloration, temperature increase, tenderness, edema, drainage, pain, swelling) and in the extremity on the side of the intervention history of mastectomy, fistula, stroke)
  • Presence of surgical intervention.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: First group
1% chlorhexidine, n=24 patients.
Other: Effects of Chlorhexidine Solutions with Different Concentrations in Preventing Peripheral Venous Catheter-Associated Infections
Chlorhexidine solution in different concentrations (1%, 2%, 4%) will applied to the 3 determined experimental groups, and 70% alcohol solution will applied to the control group. Its effects in preventing peripheral venous catheter-associated infection will compared.
Experimental: Second group
2% chlorhexidine, n=24 patients.
Other: Effects of Chlorhexidine Solutions with Different Concentrations in Preventing Peripheral Venous Catheter-Associated Infections
Chlorhexidine solution in different concentrations (1%, 2%, 4%) will applied to the 3 determined experimental groups, and 70% alcohol solution will applied to the control group. Its effects in preventing peripheral venous catheter-associated infection will compared.
Experimental: Third group
4% chlorhexidine, n=24 patients.
Other: Effects of Chlorhexidine Solutions with Different Concentrations in Preventing Peripheral Venous Catheter-Associated Infections
Chlorhexidine solution in different concentrations (1%, 2%, 4%) will applied to the 3 determined experimental groups, and 70% alcohol solution will applied to the control group. Its effects in preventing peripheral venous catheter-associated infection will compared.
Other: Fourth group
control group, 70% iso-propyl alcohol, n=24 patients.
Other: Effects of Chlorhexidine Solutions with Different Concentrations in Preventing Peripheral Venous Catheter-Associated Infections
Chlorhexidine solution in different concentrations (1%, 2%, 4%) will applied to the 3 determined experimental groups, and 70% alcohol solution will applied to the control group. Its effects in preventing peripheral venous catheter-associated infection will compared.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
H0
Time Frame: one year

Different concentrations of chlorhexidine solutions have no effect on preventing peripheral venous catheter-related infections.

1%, 2% and 4% of chlorhexidine-gluconate solutions will compared with the 70% alcohol for skin antisepsis of PVC in ICU patients. Specimens will collected by swabbing the peripheral venous catheter entry site from the patients within before,1st and 96th hours of catheterization, respectively. The culture incubate at 37 C overnight on EMB and sheep blod agar plate. Then, the reproduction of microorganisms will identified in the culture. The presence of colonization of microorganisms in EMB blood agar indicates that gram-negative microorganism growths. The presence of colonization of microorganisms in the sheep blood agar indicates that gram-positive microorganisms growths. The absence of colonization of microorganisms in both of blood agars indicates that there is no growth.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
H1
Time Frame: one year

Different concentrations of chlorhexidine solutions have effect on preventing peripheral venous catheter-related infections.

1%, 2% and 4% of chlorhexidine-gluconate solutions will compared with the 70% alcohol for skin antisepsis of PVC in ICU patients. Specimens will collected by swabbing the peripheral venous catheter entry site from the patients within before,1st and 96th hours of catheterization, respectively. The culture incubate at 37 C overnight on EMB and sheep blod agar plate. Then, the reproduction of microorganisms will identified in the culture. The presence of colonization of microorganisms in EMB blood agar indicates that gram-negative microorganism growths. The presence of colonization of microorganisms in the sheep blood agar indicates that gram-positive microorganisms growths. The absence of colonization of microorganisms in both of blood agars indicates that there is no growth.
one year

Collaborators and Investigators

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

Sponsor

Aydin Adnan Menderes University

Investigators

  • Study Director: NİHAL TAŞKIRAN, PhD, Aydin Adnan Menderes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 24, 2022

Primary Completion (Actual)

April 1, 2023

Study Completion (Actual)

July 14, 2023

Study Registration Dates

First Submitted

June 28, 2022

First Submitted That Met QC Criteria

June 28, 2022

First Posted (Actual)

July 1, 2022

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0000-0002-4598-6964

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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