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

NCT ID: NCT04821193

Last Updated: 2021-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-07

Study Completion Date

2020-07-27

Brief Summary

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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.

Detailed Description

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Intravenous therapy is one of the basic elements of modern health care. IV routes provided through catheters for pediatric patients are necessary for primary and secondary health and increase the possibility of mortality and morbidity depending on the treatment given and the factors of the patient. As in every invasive application, there are problems regarding the use of catheters, which is a minimal surgical procedure, and perhaps the most important of these is catheter-related infections.

CRI's are defined as the accompanying of both local (redness around the catheter, increased temperature, discharge, drainage, tenderness, edema) and systemic (fever, chills, changes in laboratory tests) infection findings in patients and is an important complication for children. is happening. The increase in prevalence varies among patients, as well as between cities and countries, and is among the top three among hospital-associated infections.

Although there are many studies on infections related to the use of a peripheric intravenous catheters in adult patients, it is reported that this issue is not addressed much in children. It is thought that there is no standardization regarding peripheric intravenous catheters management in the studies conducted.

Since the risk factors for infection such as body weight, concomitant chronic disease, characteristics of the catheter used and the drug administered, presence of interconnection for pediatric patients are different from adults, catheter-related infections in the pediatric age group requires a separate discussion. It cannot be denied that the main step in the prevention of catheter-related infections is the management of peripheric intravenous catheters and determining an appropriate skin antiseptic is a part of this.

In Children, 70% Alcohol, 2% Chlorhexidine Gluconate, 1% Octenidine, and 10% Povidone-iodine type antiseptics are commonly used for skin antisepsis. Sodium bicarbonate (NaHCO3) solutions are used in different areas such as oral hygiene and dental care in the world and our country, and side effects are not reported. There is limited information in the literature regarding its use as a skin antiseptic, and it is seen that this information belongs to the adult age group. There is no data on the child age group.

In this study, which was planned in two stages to determine the effectiveness of the use of sodium bicarbonate as a skin antiseptic in the prevention of catheter-related infections, the effectiveness of the antiseptics used in the first stage was evaluated in the laboratory environment against the most common microorganisms in the skin flora, and in the second stage, the use of these antiseptic solutions in skin cleansing in pediatric patients before the peripheric intravenous catheters procedure their effectiveness has been evaluated.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single blind Randomized controlled Experimental
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Single blind

Study Groups

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Experimental Group 1

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

Group Type EXPERIMENTAL

Skin antisepsis with 5% NaHCO3 water solution

Intervention Type DRUG

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

Experimental Group 2

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

Group Type EXPERIMENTAL

Skin antisepsis with 2% Chlorhexidine Gluconate solution

Intervention Type DRUG

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

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Skin antisepsis with 5% NaHCO3 water solution

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

Intervention Type DRUG

Skin antisepsis with 2% Chlorhexidine Gluconate solution

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

Intervention Type DRUG

Other Intervention Names

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Disinfectant drugs Chemical substance Disinfectant drugs Chemical substance

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Aysegul Simsek

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aysegul Simsek, PhD

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Locations

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Istanbul University-Cerrahpaşa

Istanbul, Avcilar, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 25525365 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17505372 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23692975 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21355359 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22991095 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24948414 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28104097 (View on PubMed)

Related Links

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https://www.turkiyeklinikleri.com/article/tr-klorheksidin-72909.html

Adıgüzel, Ö. (2015). Klorheksidin. Turkiye Klinikleri J Endod-Special Topics, 1(2), 15-9.

http://www.mikrobiyolbul.org/managete/fu_folder/2011-01/html/2011-45-01-086-092.htm

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.

https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5110a1.htm

12\. Centers for Disease Control and Prevention (CDC), (2002). CDC Guideline for the Prevention of Intravascular Catheter-Related Infections. MMWR August 9, 2002. (37)

Other Identifiers

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Antiseptic

Identifier Type: -

Identifier Source: org_study_id

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