- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01537835
Bacterial Contamination of Healthcare Worker Uniforms
Bacterial Contamination of Healthcare Worker Uniforms: A Study of Antimicrobial Uniforms on Occupationally Acquired Bacterial Contamination: A Randomized Controlled Trial
Healthcare worker uniforms are frequently contaminated with bacteria known to cause infections in humans. These bacteria are acquired during the workday. A new technology of antimicrobial textiles have been developed and incorporated into the fabric of health care worker uniforms, reportedly with effectiveness rates of > 99% but there is little literature describing the effectiveness of Healthcare worker (HCW) uniforms with antimicrobial properties in the clinical setting. Because of the potential benefit that such uniforms could offer HCWs and patients alike, further investigation into whether these fabrics are effective is warranted.
Up to 140 physicians, nurses, and midlevel providers who work at Denver Health on the general internal medicine wards will be invited to participate in this study. Participants will be randomized to wear either uniforms (scrubs) that have antimicrobial properties or standard scrubs provided by the hospital. At the end of an 8-hour workday, three areas on each uniform and each subject's wrist area will be cultured to assess for total bacterial colonization as well as for various resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE), and resistant gram-negative rods.
Primary Hypothesis: HCW uniforms with antimicrobial properties will have less bacterial contamination than standard uniforms (scrubs) at the end of an 8-hour workday.
Specific aim 1a. Demonstrate that antimicrobial uniforms will have less total bacterial contamination of sites swabbed compared to standard uniform after an 8-hour workday.
Specific aim 1b. Demonstrate that antimicrobial uniforms will have less antimicrobial-resistant bacterial contamination (specifically looking for MRSA, VRE, and resistant gram negatives) of sites swabbed compared to standard uniform after an 8-hour workday.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Colorado
-
Denver, Colorado, Соединенные Штаты, 80204
- Denver Health and Hospital Authority
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Physicians, nurses, and midlevel providers who work at Denver Health on the general internal medicine wards;
- Provider must be available for cultures at the end of the day, provider must be on service at Denver
- Health for the duration of the study, provider must be willing to avoid wearing white coats
Exclusion Criteria:
- Refusal to participate
- Known to be pregnant
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Без вмешательства: Standard Scrubs
Participants will be randomized to one of three types of uniforms.
This arm is the standard scrub arm.
The participants will wear new standard scrubs.
|
|
Экспериментальный: Antimicrobial Scrubs 1
Participants will be randomized to one of three types of uniforms.
In this arm, the participants will wear one of two types of antimicrobial uniforms.
These are commercially available and registered with the Environmental Protective Agency.
|
Participants will be randomized to one of three types of scrubs.
There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties.
|
Экспериментальный: Antimicrobial Scrubs 2
Participants will be randomized to one of three types of uniforms.
In this arm, the participants will wear one of two types of antimicrobial uniforms.
These are commercially available and registered with the Environmental Protective Agency.
|
Participants will be randomized to one of three types of scrubs.
There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Total Bacterial Contamination of Healthcare Worker Uniform With Antimicrobial Properties Compared to Standard Healthcare Worker Uniform After an 8-hour Workday.
Временное ограничение: 8 hours
|
Total bacterial colony count of samples obtained from the breast or lower front pocket, the sleeve cuff of the dominant hand and the pant leg at the mid-thigh of the dominant leg on all scrubs after an eight-hour workday.
|
8 hours
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Assess for Methicillin Resistent Staphylococcus Aureus, Vancomycin Resistant Enterococci, and Gram-negative Bacterial Contamination on Healthcare Worker Uniform With Antimicrobial Properties Compared to Standard Healthcare Worker Uniform.
Временное ограничение: 8 hours
|
Number of healthcare workers with methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), and resistant gram-negative bacteria on the three scrub types, all obtained after the eight-hour workday.
|
8 hours
|
Соавторы и исследователи
Соавторы
Следователи
- Главный следователь: Marisha A Burden, MD, Denver Health and Housing Authority
Публикации и полезные ссылки
Общие публикации
- Burden M, Cervantes L, Weed D, Keniston A, Price CS, Albert RK. Newly cleaned physician uniforms and infrequently washed white coats have similar rates of bacterial contamination after an 8-hour workday: a randomized controlled trial. J Hosp Med. 2011 Apr;6(4):177-82. doi: 10.1002/jhm.864. Epub 2011 Feb 10.
- Burden M, Keniston A, Frank MG, Brown CA, Zoucha J, Cervantes L, Weed D, Boyle K, Price C, Albert RK. Bacterial contamination of healthcare workers' uniforms: a randomized controlled trial of antimicrobial scrubs. J Hosp Med. 2013 Jul;8(7):380-5. doi: 10.1002/jhm.2051. Epub 2013 Jun 12.
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2-5-15504
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