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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
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Transplantation Infection

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
June 2, 2015
Last Updated
April 15, 2019
Sponsor
University of British Columbia
Collaborators
Vancouver Coastal Health Research Institute
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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

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Prevention of Healthcare Associated Infections in Bone Marrow Transplant Patients

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