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Catheter-Associated InfectionsNCT05441605

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

A study testing Effects of Chlorhexidine Solutions with Different Concentrations in Preventing Peripheral Venous Catheter-Associated Infections in people with Catheter-Associated Infections, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Catheter-Associated Infections
What is being tested?
Effects of Chlorhexidine Solutions with Different Concentrations in Preventing Peripheral Venous Catheter-Associated Infections
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteTurkey (Türkiye)
Study dates
24 Jun 2022to 14 Jul 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • TR Ministry of Health Nazilli State Hospital

    Aydin, Nazi̇lli̇, 09800

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Effects of Chlorhexidine Solutions with Different Concentrations in Preventing Peripheral Venous Catheter-Associated Infections
Keywords
Catheter-Associated Infections, peripheral venous catheter, chlorhexidine, skin antisepsis
Medical subject headings
Catheter-Related Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Effects of Chlorhexidine Solutions with Different Concentrations in Preventing Peripheral Venous Catheter-Associated InfectionsOther

    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.

Study groups in NCT05441605
Study groupRoleWhat they receive
First groupExperimental1% chlorhexidine, n=24 patients.
Receives: Other: Effects of Chlorhexidine Solutions with Different Concentrations in Preventing Peripheral Venous Catheter-Associated Infections
Second groupExperimental2% chlorhexidine, n=24 patients.
Receives: Other: Effects of Chlorhexidine Solutions with Different Concentrations in Preventing Peripheral Venous Catheter-Associated Infections
Third groupExperimental4% chlorhexidine, n=24 patients.
Receives: Other: Effects of Chlorhexidine Solutions with Different Concentrations in Preventing Peripheral Venous Catheter-Associated Infections
Fourth groupOthercontrol group, 70% iso-propyl alcohol, n=24 patients.
Receives: Other: Effects of Chlorhexidine Solutions with Different Concentrations in Preventing Peripheral Venous Catheter-Associated Infections

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. H0

    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.

    Measured: one year

Secondary outcomes (1)
  1. H1

    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.

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2022
  2. Study start24 Jun 2022
  3. Primary completion1 Apr 2023
  4. Study completion14 Jul 2023

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This research is a randomized controlled double-blinded experimental design. First experimental group, 1% chlorhexidine, n=24 patients, second experimental group, 2% chlorhexidine, n=24 patients, third experimental group, 4% chlorhexidine, n=24 patients, control group, 70% iso-propyl alcohol, n=24 patients
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05441605
Sponsor's protocol ID
0000-0002-4598-6964
Status last verified
Jan 2024
First submitted
28 Jun 2022
Last updated
31 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Araujo T, Rodriguez LP, Patel SA. Does my patient need a peripheral intravenous catheter? Br J Hosp Med (Lond). 2020 Jan 2;81(1):1-3. doi: 10.12968/hmed.2019.0151. Epub 2020 Jan 28. No abstract available.

    PubMed 32003618
  • Marsh N, Webster J, Mihala G, Rickard CM. Devices and dressings to secure peripheral venous catheters to prevent complications. Cochrane Database Syst Rev. 2015 Jun 12;2015(6):CD011070. doi: 10.1002/14651858.CD011070.pub2.

    PubMed 26068958
  • Alexandrou E, Ray-Barruel G, Carr PJ, Frost SA, Inwood S, Higgins N, Lin F, Alberto L, Mermel L, Rickard CM; OMG Study Group. Use of Short Peripheral Intravenous Catheters: Characteristics, Management, and Outcomes Worldwide. J Hosp Med. 2018 May 30;13(5). doi: 10.12788/jhm.3039.

    PubMed 29813140
  • Wallis MC, McGrail M, Webster J, Marsh N, Gowardman J, Playford EG, Rickard CM. Risk factors for peripheral intravenous catheter failure: a multivariate analysis of data from a randomized controlled trial. Infect Control Hosp Epidemiol. 2014 Jan;35(1):63-8. doi: 10.1086/674398. Epub 2013 Dec 2.

    PubMed 24334800
  • Keleekai NL, Schuster CA, Murray CL, King MA, Stahl BR, Labrozzi LJ, Gallucci S, LeClair MW, Glover KR. Improving Nurses' Peripheral Intravenous Catheter Insertion Knowledge, Confidence, and Skills Using a Simulation-Based Blended Learning Program: A Randomized Trial. Simul Healthc. 2016 Dec;11(6):376-384. doi: 10.1097/SIH.0000000000000186.

    PubMed 27504890
  • Macias AE, Huertas M, de Leon SP, Munoz JM, Chavez AR, Sifuentes-Osornio J, Romero C, Bobadilla M. Contamination of intravenous fluids: a continuing cause of hospital bacteremia. Am J Infect Control. 2010 Apr;38(3):217-21. doi: 10.1016/j.ajic.2009.08.015. Epub 2009 Dec 23.

    PubMed 20031270
  • Choudhury MA, Sidjabat HE, Zowawi HM, Marsh PhD N, Larsen E, Runnegar PhD N, Paterson DL, McMillan DJ, Rickard CM. Skin colonization at peripheral intravenous catheter insertion sites increases the risk of catheter colonization and infection. Am J Infect Control. 2019 Dec;47(12):1484-1488. doi: 10.1016/j.ajic.2019.06.002. Epub 2019 Jul 19.

    PubMed 31331714
  • Noorani A, Rabey N, Walsh SR, Davies RJ. Systematic review and meta-analysis of preoperative antisepsis with chlorhexidine versus povidone-iodine in clean-contaminated surgery. Br J Surg. 2010 Nov;97(11):1614-20. doi: 10.1002/bjs.7214.

    PubMed 20878942
  • Bilir A, Yelken B, Erkan A. Cholorhexidine, octenidine or povidone iodine for catheter related infections: A randomized controlled trial. J Res Med Sci. 2013 Jun;18(6):510-2.

    PubMed 24250702
  • Yamamoto N, Kimura H, Misao H, Matsumoto H, Imafuku Y, Watanabe A, Mori H, Yoshida A, Miura S, Abe Y, Toba M, Suzuki H, Ogawa K, Kanemitsu K. Efficacy of 1.0% chlorhexidine-gluconate ethanol compared with 10% povidone-iodine for long-term central venous catheter care in hematology departments: a prospective study. Am J Infect Control. 2014 May;42(5):574-6. doi: 10.1016/j.ajic.2013.12.023. Epub 2014 Mar 18.

    PubMed 24655901
  • Ohtake S, Takahashi H, Nakagawa M, Uchino Y, Miura K, Iriyama N, Nakayama T, Hatta Y, Takei M. One percent chlorhexidine-alcohol for preventing central venous catheter-related infection during intensive chemotherapy for patients with haematologic malignancies. J Infect Chemother. 2018 Jul;24(7):544-548. doi: 10.1016/j.jiac.2018.03.001. Epub 2018 Apr 4.

    PubMed 29627326
  • Capdevila JA, Guembe M, Barberan J, de Alarcon A, Bouza E, Farinas MC, Galvez J, Goenaga MA, Gutierrez F, Kestler M, Llinares P, Miro JM, Montejo M, Munoz P, Rodriguez-Creixems M, Sousa D, Cuenca J, Mestres CA; on behalf the SEICAV, SEMI, SEQ and SECTCV Societies. 2016 Expert consensus document on prevention, diagnosis and treatment of short-term peripheral venous catheter-related infections in adult. Rev Esp Quimioter. 2016 Aug;29(4):230-8. Epub 2016 Aug 28.

    PubMed 27580009

Questions about this trial

What is this clinical trial studying?

A study testing Effects of Chlorhexidine Solutions with Different Concentrations in Preventing Peripheral Venous Catheter-Associated Infections in people with Catheter-Associated Infections, run by Aydin Adnan Menderes 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 6 inclusion and 5 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 31 Jan 2024. 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?

H0 (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05441605, which also lists 12 linked publications.

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 31 Jan 2024.

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