Prevention of Healthcare Associated Infections in Bone Marrow Transplant Patients
Primary Purpose
Transplantation Infection
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Engineered Room
Sponsored by
About this trial
This is an interventional prevention trial for Transplantation Infection
Eligibility Criteria
Inclusion Criteria (Patients):
- undergoing allogenic bone marrow transplant for acute myeloid leukemia
- will be admitted to the leukemia and bone marrow transplant service at Vancouver General Hospital
- admission to the ward anticipated to be approximately 28 days
Exclusion Criteria (Patients):
- allergies to copper, nickel or titanium
- patients admitted for stays anticipated to be less than 28 days
Inclusion Criteria (Health care worker):
- undergoing allogenic bone marrow transplant for acute myeloid leukemia
- caring for patient enrolled in the study as a primary nurse
Exclusion Criteria (Health care worker):
- allergies to copper, nickel or titanium
Sites / Locations
- Vancouver General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard Room
Engineered Room
Arm Description
Standard bone marrow transplant recovery, single occupancy, room
Single occupancy bone marrow transplant recovery room, engineered with touchless devices, and surfaces coated with either copper or titanium dioxide.
Outcomes
Primary Outcome Measures
Change in bioburden on surfaces
Looking to see the effectiveness of copper and titanium on the microbiota in the environment of the recovery room.
Secondary Outcome Measures
Full Information
NCT ID
NCT02463214
First Posted
June 2, 2015
Last Updated
April 15, 2019
Sponsor
University of British Columbia
Collaborators
Vancouver Coastal Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02463214
Brief Title
Prevention of Healthcare Associated Infections in Bone Marrow Transplant Patients
Official Title
Prevention of Healthcare Associated Infections in Bone Marrow Transplant Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Vancouver Coastal Health Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study involves sampling bone marrow transplant patients, hospital workers and the patient room for microbes using swabs and other techniques. We send these samples to the laboratory, where they will use state-of-the art technology to identify and relate the microbes to each other. This study also involves putting copper, nickel, or titanium into some hospital rooms, and seeing whether these metals influences the growth of microbes. Some equipment in the hospital room, such as faucets and soap dispensers will be replaced by sensor-based (e.g. touchless) controls.
Detailed Description
Bacteria and other microbes are everywhere, the majority of which are harmless. They live on our bodies, on everyday objects, in food, and in our environment. They are passed around through the many interactions with other people and our surroundings. Some are even beneficial, helping us digest our food or protecting us from infections caused by harmful microbes.
In rare instances, some of the harmful microbes can cause infections. When a microbe causes an infection while we are in healthcare facilities, they are called "Healthcare-associated infections", or "HAIs". Examples that you may have heard of include Clostridium difficile, and MRSA (methicillin-resistant Staphylococcus aureus). Vancouver General Hospital already has some of the lowest HAI rates in the country. We have dedicated hospital workers that do a great job at preventing HAIs, but we are always looking for ways to be even better.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transplantation Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Room
Arm Type
No Intervention
Arm Description
Standard bone marrow transplant recovery, single occupancy, room
Arm Title
Engineered Room
Arm Type
Experimental
Arm Description
Single occupancy bone marrow transplant recovery room, engineered with touchless devices, and surfaces coated with either copper or titanium dioxide.
Intervention Type
Other
Intervention Name(s)
Engineered Room
Intervention Description
Touchless devices:
Hand sanitizers, faucets, paper towel dispensers, call devices, Ultraviolet C Aseptix™ Disinfection devices above bathroom doors
Copper products:
Room and bathroom entrance door hardware, over bed table and bed side table surfaces, chair metal arms, wardrobe handles and knobs, weigh scale, sinks, grab bars, light switch panels, toilet flush handles, faucets and handles, patient bed rails.
Titanium dioxide paint:
Room walls, head walls, light switches, bathroom wall shelves, toilet tank and bowl, head wall unit fixed equipment, television remote and Bed Control remote
Primary Outcome Measure Information:
Title
Change in bioburden on surfaces
Description
Looking to see the effectiveness of copper and titanium on the microbiota in the environment of the recovery room.
Time Frame
up to 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (Patients):
undergoing allogenic bone marrow transplant for acute myeloid leukemia
will be admitted to the leukemia and bone marrow transplant service at Vancouver General Hospital
admission to the ward anticipated to be approximately 28 days
Exclusion Criteria (Patients):
allergies to copper, nickel or titanium
patients admitted for stays anticipated to be less than 28 days
Inclusion Criteria (Health care worker):
undergoing allogenic bone marrow transplant for acute myeloid leukemia
caring for patient enrolled in the study as a primary nurse
Exclusion Criteria (Health care worker):
allergies to copper, nickel or titanium
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Hoang, MD FRCPC
Organizational Affiliation
The University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elizabeth Bryce, MD FRCPC
Organizational Affiliation
The University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrick Tang, MD PhD FRCPC
Organizational Affiliation
Sidra Medical and Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Prevention of Healthcare Associated Infections in Bone Marrow Transplant Patients
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