Benefits of Universal Glove and Gowning (NCT01318213) | Clinical Trial Compass
CompletedNot Applicable
Benefits of Universal Glove and Gowning
United States19,856 participantsStarted 2010-12
Plain-language summary
This study will test if doctors, nurses and other people who take care of patients in hospitals wearing gloves and gown for all contact with patients in an intensive care unit (ICU) will:
* Decrease the chance of patients getting an infection while in the hospital
* Decrease the chance of patients picking up bacteria as a result of being in the hospital
* Decrease the time a patient spends in the ICU or in the hospital
* Increase the frequency of adverse events
The study will also look at whether making doctors, nurses and other people who take care of patients wear gloves and gown for all contact with patients will decrease the amount of time healthcare workers spend with patients.
This study will gather information by comparing what happens in ICUs that continue to do what they were doing before the study with what happens in ICUs that require healthcare workers to wear gloves and gown for all contact with patients.
This study will provide information that will help to make being in the hospital safer for all patients.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
ICUs to be included are: adult medical, surgical or combined medical surgical ICU as defined below:
* Medical ICU (MICU) \> 80% of patients have a medical condition and have not undergone a surgical procedure during the current hospital stay
* Surgical ICU (SICU) \> 80% of the patients have undergone a surgical procedure during the current hospital stay
* Combined Medical/Surgical ICU (MICU/SICU) - a roughly equivalent mixture of patients with medical conditions who have not undergone surgical procedures and patients who have undergone surgical procedures during the current hospital stay. Each group makes up \> 20% and less than 80% of the total number of patients
* Ability to collect the data required for analysis
* Written approval of the study from the institution's IRB. The institution may opt to use the IRB approval provided by the centralized IRB at the University of Maryland, School of Medicine
* Memorandum of Understanding signed by the ICU Medical Director, ICU Nurse Manager or Director and the Hospital Epidemiologist indicating a commitment to supporting enrollment of an ICU and completion the study
* Ability to be matched with another ICU based on baseline acquisition of resistant bacteria on culture
* Agreement to not perform active surveillance for MRSA or VRE that will be fed back to patients during the study period
Exclusion Criteria:
Pediatric ICUs and other non-medical or non-surgical ICUs will be excluded
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.