Evaluation of the Effectiveness of a Waterless Hygiene Technology for Totally Dependent Hospitalized Patients: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 468
- 试验地点
- 4
- 主要终点
- Microbial load : effectiveness of the perineal hygiene with pre-moistened wipes
研究概览
简要总结
The aim of this randomized controlled trial is to verify whether the efficacy of perineal hygiene procedures performed in dependent patients admitted to medical or geriatric wards with pre-moistened wipes without water is higher than that found after procedures performed with disposable hand grips, soap, and water.
详细描述
Patients hospitalized in medicine and geriatrics wards will be admitted, both for scheduled and urgent hospitalizations. If the patient meets the study inclusion criteria, we will proceed with the description of the study, the delivery of the information form and the collection of informed consent. Only after signing the consent, the patient can be enrolled in the study. The day following enrollment, the first perineal hygiene in the morning will be performed with pre-moistened wipes without water or with disposable hand grips, soap and water depending on the study group to which the patient has been randomly assigned.
In both groups, a skin swab will be performed before and after the hygiene practice, after which the patient will leave the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Patients over 18 years of age inclusive at the time of the study;
- •Patients admitted to medical or geriatric wards with scheduled or urgent hospitalization;
- •Hypothesis of hospitalization of at least 48 hours
- •Totally dependent patients who are bedridden and unable to independently provide for their own personal hygiene.
- •Patient-oriented in time and space/cognitively cooperative.
- •Acquisition of written informed consent.
排除标准
- •Patients who have performed perineal hygiene with wipes or other methods containing antiseptic solutions in the 12-24 hours preceding the execution of the swab for the bacteriological examination.
- •Patients who have undergone a treatment procedure in the groin and/or perineal area that required skin antisepsis (e.g. femoral blood sampling, bladder catheter insertion, etc.).
- •Patients with known allergies to one of the components of the products used.
- •Patients diagnosed with dermatological pathologies.
- •Patients colonized or infected with microorganisms transmissible by contact.
- •Patients in bowel cleansing preparation for diagnostic procedures e therapeutic.
- •Patients with diarrheal bowel.
- •Patients hospitalized on Saturdays and Sundays due to the difficulty of illustrating information and acquiring informed consent since healthcare professionals are small in number.
- •Patient enrolled and then transferred to another ward or discharged before 48 hours.
研究组 & 干预措施
Experimental group
Participants enrolled in the experimental arm will receive a perineal hygiene with pre-moistened wipes without water.
干预措施: Pre-moistened wipes (Procedure)
Control group
Participants enrolled in the no intervention arm will receive perineal hygiene with soapy disposable knobs and water.
结局指标
主要结局
Microbial load : effectiveness of the perineal hygiene with pre-moistened wipes
时间窗: One day
The primary objective is to verify whether the effectiveness of perineal hygiene procedures performed in hospitalized dependent patients admitted to medical or geriatric wards using pre-moistened waterless wipes (experimental treatment) is superior to that achieved with standard soap-and-water hygiene. Each participant undergoes one pre-procedure (T0) and one post-procedure (T1) perineal swab for microbiological assessment. According to the prospectively approved study protocol, microbiological success is predefined as achievement of a ≥90% reduction in total viable microbial load (CFU) from baseline (T0) to post-procedure (T1). The primary analysis compares the proportion of participants achieving this predefined endpoint between study groups.
次要结局
- Examine the patient-operator concordance regarding the different aspects relating to the liking for the two hygiene methodologies(One day)
- Compare the patients' satisfaction with the two hygiene methods(One day)
- Compare the approval of health professionals for the two hygiene methods(One day)
- Compare the total costs of the aids used in the two hygiene methods(One day)
- Compare the working times referred to the two hygiene methods(One day)
研究者
Lea Godino
Principal Investigator - Research Nurse
IRCCS Azienda Ospedaliero-Universitaria di Bologna