Clinical trial NCT05441605: Effect of Chlorhexidine Solution in Preventing Peripheral Venous Catheter Associated-Infection
Official title: Effects of Chlorhexidine Solutions With Different Concentrations in Preventing Peripheral Venous Catheter-Associated Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter-Associated Infections
Keywords: Catheter-Associated Infections
peripheral venous catheter
chlorhexidine
skin antisepsis
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2022-07-01
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: H0
timeFrame: one year
Secondary outcomes:
measure: H1
timeFrame: one year
Other outcomes:
Locations:
city: Aydin
country: Turkey
facility: TR Ministry of Health Nazilli State Hospital
state: Nazi̇lli̇
Study officials:
affiliation: Aydin Adnan Menderes University
name: NİHAL TAŞKIRAN, PhD
role: STUDY_DIRECTOR
References:
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