Comparison of the Effects of 5%NaHCO3, 2%CHG and 70%Alcohol in the Prevention of Infections Related to Catheter

NCT04821193 | Completed

• 1 other identifier: Antiseptic
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Intravenous catheters have become one of the indispensable tools of modern medicine. Peripheric intravenous catheters facilitate the work of healthcare professionals in the treatment phase, especially in diagnostic procedures. Intravenous catheters cause microorganisms to enter the bloodstream by damaging the skin, which is the body's first defense barrier. In this case, it causes infections, sepsis, an increase in mortality and morbidity rates, prolongation of hospital stay, increase in antibiotic use, and medical expenses. The density of the skin flora in the area where the catheter will be inserted is a major risk factor for infection.To prevent complications associated with peripheric intravenous catheters; Performing the procedure in line with the principles of surgical asepsis and following the correct follow-up are among the most important measures that the nurse should take. Also, the child and the parents should be prepared for the procedure and the appropriate environment should be provided. Along with correct catheter placement and care, antisepsis of the cannula placement area is among the indicators of nursing care. As well as the effectiveness and safety of skin disinfectants, topical absorption, lack of toxic effect, local and irritation effect are also important. Solutions with 5% NaHCO3 have recently come to the fore as antiseptic agents. When the literature is examined, it has not been found that there are very few studies on this solution and it is used in skin antisepsis before peripheral intravenous catheterization in children. This study was planned as a randomized controlled experimental design to determine the effectiveness of 5% NaHCO3 water solution in catheter site cleaning in pediatric patients by comparing it with the most commonly used antiseptic agents and to monitor the development of catheter-related infections.

Conditions

Disinfectant Dye Adverse Reaction; Catheter-Related Infections; Nursing Caries; Children, Only; Skin Lesion; Chlorhexidine Adverse Reaction; Catheter

Keywords

Antiseptic; Intravenous catheterization; Catheter-related infection; Chlorhexidine gluconate; Sodium bicarbonate

Outcome Measures

Primary Outcomes (1)

• The effectiveness of the solutions - In-vitro analysis

  Effectiveness in the laboratory: The efficacy of the solutions on the most common bacteria on the skin was tested in the laboratory. Analysis of solutions to be used in Laboratory Environment (In vitro): 5% NaHCO3 water solution, 2% KHG solution and 70% Alcohol solution to be used in the catheterization process were studied in the laboratory with the microbiologist in the blood, Müller Hinton agar with disk diffusion method. The diameter of the discs used is 9 mm. Microorganisms are clinical isolates. As a result, they are the inhibition zones recorded.

  One months

Secondary Outcomes (1)

• The effectiveness of the solutions - Practice

  Five months

Other Outcomes (12)

• Efficacy and Safety: Vital signs - Body temperature

  Twelve hours, 15 minutes, 2 repeated measurements

• Efficacy and Safety: Vital signs- Heart rate

  Twelve hours, 15 minutes, 2 repeated measurements

• Efficacy and Safety: Vital Signs - Blood pressure

  Twelve hours, 15 minutes, 2 repeated measurements

Study Arms (3)

Experimental Group 1

EXPERIMENTAL

Cleansing the skin with an antiseptic solution before intravenous catheterization Skin antisepsis with 5% NaHCO3 water solution group Grup number: 20

Drug: Skin antisepsis with 5% NaHCO3 water solution

Experimental Group 2

EXPERIMENTAL

Cleansing the skin with an antiseptic solution before intravenous catheterization Skin antisepsis with 2% Chlorhexidine Gluconate solution group Grup number: 21

Drug: Skin antisepsis with 2% Chlorhexidine Gluconate solution

Control Group

NO INTERVENTION

Cleansing the skin with an antiseptic solution before intravenous catheterization Skin antisepsis with 70% Alcohol solution group Grup number: 21

Interventions

Skin antisepsis with 5% NaHCO3 water solution DRUG

In-vitro analysis of the solutions was done first. Then solutions were applied, and peripheric intravenous catheter was installed

Also known as: Disinfectant drugs, Chemical substance

Experimental Group 1

Skin antisepsis with 2% Chlorhexidine Gluconate solution DRUG

In-vitro analysis of the solutions was done first. Then solutions were applied, and peripheric intravenous catheter was installed

Also known as: Disinfectant drugs, Chemical substance

Experimental Group 2

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Being between the ages of 1-18
• Having inpatient treatment in pediatric clinics
• No previous history of catheter-related infections
• No history of systemic infection
• Absence of immunological disease
• Not using antibiotherapy
• No scar/scar tissue on the skin in the catheterization area

You may not qualify if:

• Being an inpatient who does not need intravenous treatment
• Finding an infection
• Having a chronic skin disease
• Having a history of allergies
• Being a newborn

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpaşa

Istanbul, Avcilar, 34320, Turkey (Türkiye)

Location

Related Publications (7)

• Abolfotouh MA, Salam M, Bani-Mustafa A, White D, Balkhy HH. Prospective study of incidence and predictors of peripheral intravenous catheter-induced complications. Ther Clin Risk Manag. 2014 Dec 8;10:993-1001. doi: 10.2147/TCRM.S74685. eCollection 2014.

  PMID: 25525365 BACKGROUND

• Adams D, Elliot TS. Skin antiseptics used prior to intravascular catheter insertion. Br J Nurs. 2007 Mar 8-21;16(5):278-80. doi: 10.12968/bjon.2007.16.5.22997.

  PMID: 17505372 BACKGROUND

• Berry AM. A comparison of Listerine(R) and sodium bicarbonate oral cleansing solutions on dental plaque colonisation and incidence of ventilator associated pneumonia in mechanically ventilated patients: a randomised control trial. Intensive Crit Care Nurs. 2013 Oct;29(5):275-81. doi: 10.1016/j.iccn.2013.01.002. Epub 2013 May 19.

  PMID: 23692975 BACKGROUND

• Bolton D. Improving peripheral cannulation practice at an NHS Trust. Br J Nurs. 2010 Nov 25-Dec 8;19(21):1346, 1348-50. doi: 10.12968/bjon.2010.19.21.79998.

  PMID: 21355359 BACKGROUND

• Letscher-Bru V, Obszynski CM, Samsoen M, Sabou M, Waller J, Candolfi E. Antifungal activity of sodium bicarbonate against fungal agents causing superficial infections. Mycopathologia. 2013 Feb;175(1-2):153-8. doi: 10.1007/s11046-012-9583-2. Epub 2012 Sep 19.

  PMID: 22991095 BACKGROUND

• Ding L, Wu HL, Zhu JH, Ding M, Wang YL, Xu XJ. Superiority of 5% NaHCO3 for preoperative hair removal in patients undergoing coronary artery bypass graft surgery with a limb vein: a randomized controlled trialdagger. Eur J Cardiothorac Surg. 2014 Aug;46(2):e28-32. doi: 10.1093/ejcts/ezu203. Epub 2014 Jun 18.

  PMID: 24948414 BACKGROUND

• Wu HL, Xu YH, Shi JH. 5% NaHCO3 Is Appropriate for Skin Cleaning With Central Venous Catheters. Am J Med Sci. 2017 Jan;353(1):12-16. doi: 10.1016/j.amjms.2016.10.010. Epub 2016 Oct 29.

  PMID: 28104097 BACKGROUND

Related Links

• Adıgüzel, Ö. (2015). Klorheksidin. Turkiye Klinikleri J Endod-Special Topics, 1(2), 15-9.
• Aktaş, E., Sarı, E.N., Seremet Keskin, A., Pişkin, N., Külah, C., Cömert, F. (2011) Damar İçi Kateter ile İlişkili Enfeksiyon Etkenleri ve Antibiyotik Duyarlılıkları. Mikrobiyoloji Bülteni, 45(1), 86-92.
• 12\. Centers for Disease Control and Prevention (CDC), (2002). CDC Guideline for the Prevention of Intravascular Catheter-Related Infections. MMWR August 9, 2002. (37)

MeSH Terms

Conditions

Catheter-Related Infections

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Aysegul Simsek, PhD

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single blind Randomized controlled Experimental

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 29, 2021
• Study Start: November 7, 2017
• Primary Completion: July 27, 2020
• Study Completion: July 27, 2020
• Last Updated: March 29, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)