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临床试验/NCT04347057
NCT04347057已完成不适用

The Effect of Bathing With Chlorhexidine on MRSA and VRE Colonization in Hematology and Oncology Inpatients

Hacettepe University1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2018年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
1
主要终点
MRSA and/or VRE skin colonization rates

研究概览

简要总结

Hospital-acquired infections (HIs) are defined as an infection developed within 48-72 hours of admission to hospital in whom the infection was not incubating at the time of admission to the hospital or an infection acquired in the hospital but appearing 10 days after discharged. Hospital infections threaten patient safety due to the complications they cause, even if they are preventable problems. Staphylococcus aureus and enterococci which cause hospital infections are among the important pathogens in terms of antibiotic resistance development (MRSA: Methicillin-resistant Staphylococcus aureus, VRE: Vancomycin-resistant Enterococcus).

Patients undergoing treatment in ICU are at a higher risk of infection than patients in other units of the hospital because of the seriousness of their condition and their high exposure to invasive procedures. MRSA and VRE are two important microorganism types that cause infection in patients who are hospitalized in ICU and take long-term care.

In general, international recommendations for prevention and control of hospital infections include handwashing and individual hygiene practices with skin antisepsis. Chlorhexidine gluconate is a broad-spectrum antimicrobial and bacteria killing agent that causes less irritation to skin. In the literature, bathing with various concentrations of chlorhexidine has been shown to significantly reduce the MRSA and VRE contamination risk and skin colonization. These studies are mostly performed in medical, surgical or cardiology ICU but there are very limited studies in the hematology-oncology patients who are more susceptible for the hospital infections because of the their illnesses and treatments.

According to the crossover design; patients who meet the sampling inclusion criteria within the first 24 hours of the ICU admission will be randomly separated two arm (n = 30 for each arm) and bath applications will be performed. After the first swab sample will be taken; the control and intervention bathing protocols will be applied to each group of patients. To evaluate the effectiveness of the bath product another swab sample will be taken after 4-6 hours after the bathing.

It is thought that to study on this subject is very important because of the bath bathing which is a personal hygiene practices is a basic nursing application and there is a limited literature information about the effectiveness of these bathing on to prevent the infections in our country and a limited world and national literature information with cancer patients. The results obtained from the research will be contributing the literature and searching area of the prevention and control of hospital infections and will be provide the guidance on the development of patient care quality

详细描述

The study was designed as an experimental, 2-arm, cross-over clinical trial, involving patients admitted to ICU of a university oncology hospital between September 2018 and July 2019.

This study was conducted at one medical intensive care unit of an oncology hospital, which is one of the four hospitals of a state university located at the capital city of Turkey. The University is the first public institution in Turkey accredited by the Joint Commission International (JCI) for its quality of health care services. The ICU of the oncology hospital provides care for patients with a variety of medical conditions, but particularly specialized for critical patients with oncological and haematological diseases. The ICU includes eight beds and two isolation rooms each of which has one patient bed, and the average daily admission of patients to ICU was 7.

Using the NCSS-PASS 2007 statistical package program (Blackwelder, 1998), the minimum sample size with 80.0% power and type 1 error of 5.0% was calculated as 58 patients for an inclusion period of 1 year; however 61 patients who met the inclusion criteria composed the study sample.

All patients admitted to the ICU were assessed for eligibility and included to the study sample if they aged over 18 years, diagnosed with a hematologic-oncologic disease and admitted within the first 24 hours to the ICU. Exclusion criteria for participation were; age < 18 years, burns to >20% of the total skin surface, pregnancy, previous MRSA and/or VRE infection history or antibiotic use for these infections, receiving radiation therapy, admitted before 24 hours to ICU, re-admission to ICU, diagnosed with severe septic shock, massive pulmonary thromboembolism, massive haemoptysis, and status epilepticus etc., general condition disorder.

A total of 139 patients with a hematologic-oncologic disease were assessed for eligibility of whom 61 excluded due to discharge (n=11) or death (n=6) before 24 hours of hospitalization, admission to ICU before the eligibility assessment of researcher (n=8), repeated admission to ICU (n=6), severely impaired medical condition (n=6), age under 18 years (n=2), massive pulmonary thromboembolism (n=2), previous MRSA infection (n=2), and severe septic shock (n=1). Seventeen patients did not provide consent for participation and their relatives were not available. After eligibility assessment, 78 patients were randomised into two arms according to the order of admission to the ICU. Arm 1 (39 patients) included first the control period, followed by one-day wash-out, and then the intervention period. Arm 2 (39 patients) included first the intervention period, followed by one-day wash-out, and then the control period. The first patient was assigned to the second arm after the draw, and the patients continued to take the first arm and second arm respectively. Each period lasted three consecutive days with a total of 7 days for each patient. During the period of the study, 8 patients from Arm1 and 9 patients from Arm 2 could not complete the study due to several reasons. Thus, the final sample consisted of 31 patients in Arm 1 and 30 patients in Arm 2.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Aged over 18 years Diagnosed with a hematologic-oncologic disease Admitted within the first 24 hours to the ICU

排除标准

  • •Age < 18 years Burns to >20% of the total skin surface Pregnancy Previous MRSA and/or VRE infection history or antibiotic use for these infections Receiving radiation therapy Admitted before 24 hours to ICU Re-admission to ICU Diagnosed with severe septic shock, massive pulmonary thromboembolism, massive haemoptysis, and status epilepticus General condition disorder

研究组 & 干预措施

Arm 1

Experimental

Arm 1 (39 patients) included first the control period, followed by one-day wash-out, and then the intervention period.

Procedures for control period included providing daily bed bathing with soap and water over three consecutive days, while intervention period included daily bed bathing with 2% CHG solution over three consecutive days.

干预措施: Bed bathing with 2% CHG solution (Other)

Arm 1

Experimental

Arm 1 (39 patients) included first the control period, followed by one-day wash-out, and then the intervention period.

Procedures for control period included providing daily bed bathing with soap and water over three consecutive days, while intervention period included daily bed bathing with 2% CHG solution over three consecutive days.

干预措施: Bed bathing with soap and water (Other)

Arm 2

Experimental

Arm 2 (39 patients) included first the intervention period, followed by one-day wash-out, and then the control period.

Procedures for control period included providing daily bed bathing with soap and water over three consecutive days, while intervention period included daily bed bathing with 2% CHG solution over three consecutive days.

干预措施: Bed bathing with 2% CHG solution (Other)

Arm 2

Experimental

Arm 2 (39 patients) included first the intervention period, followed by one-day wash-out, and then the control period.

Procedures for control period included providing daily bed bathing with soap and water over three consecutive days, while intervention period included daily bed bathing with 2% CHG solution over three consecutive days.

干预措施: Bed bathing with soap and water (Other)

结局指标

主要结局

MRSA and/or VRE skin colonization rates

时间窗: 8 days for all participants

Wiping baths with 2% CHG solution would have lower MRSA and/or VRE skin colonization rates with statistically significant differences compared to the soap and water baths

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gul Hatice TARAKCIOGLU CELIK

Department of Fundamentals of Nursing, Faculty of Nursing

Hacettepe University

研究点 (1)

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