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

NCT05441605 | Completed

• 1 other identifier: 0000-0002-4598-6964
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Catheter-Associated Infections

Keywords

Catheter-Associated Infections; peripheral venous catheter; chlorhexidine; skin antisepsis

Outcome Measures

Primary Outcomes (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.

  one year

Secondary Outcomes (1)

• H1

  one year

Study Arms (4)

First group

EXPERIMENTAL

1% chlorhexidine, n=24 patients.

Other: Effects of Chlorhexidine Solutions with Different Concentrations in Preventing Peripheral Venous Catheter-Associated Infections

Second group

EXPERIMENTAL

2% chlorhexidine, n=24 patients.

Other: Effects of Chlorhexidine Solutions with Different Concentrations in Preventing Peripheral Venous Catheter-Associated Infections

Third group

EXPERIMENTAL

4% chlorhexidine, n=24 patients.

Other: Effects of Chlorhexidine Solutions with Different Concentrations in Preventing Peripheral Venous Catheter-Associated Infections

Fourth group

OTHER

control group, 70% iso-propyl alcohol, n=24 patients.

Other: Effects of Chlorhexidine Solutions with Different Concentrations in Preventing Peripheral Venous Catheter-Associated Infections

Interventions

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

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.

First group; Fourth group; Second group; Third group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

TR Ministry of Health Nazilli State Hospital

Aydin, Nazi̇lli̇, 09800, Turkey (Türkiye)

Location

Related Publications (12)

• 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.

  PMID: 32003618 BACKGROUND

• 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.

  PMID: 26068958 BACKGROUND

• 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.

  PMID: 29813140 BACKGROUND

• 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.

  PMID: 24334800 BACKGROUND

• 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.

  PMID: 27504890 BACKGROUND

• 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.

  PMID: 20031270 BACKGROUND

• 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.

  PMID: 31331714 BACKGROUND

• 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.

  PMID: 20878942 BACKGROUND

• 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.

  PMID: 24250702 BACKGROUND

• 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.

  PMID: 24655901 BACKGROUND

• 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.

  PMID: 29627326 BACKGROUND

• 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.

  PMID: 27580009 BACKGROUND

MeSH Terms

Conditions

Catheter-Related Infections

Condition Hierarchy (Ancestors)

Infections

Study Officials

• NİHAL TAŞKIRAN, PhD

  Aydin Adnan Menderes University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A double-blind, experimental type of study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 1, 2022
• Study Start: June 24, 2022
• Primary Completion: April 1, 2023
• Study Completion: July 14, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)