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IMPACT STUDY: Investigating Microbial Pathogen Activity of Copper Textiles (IMPACT)

Primary Purpose

Critically Ill

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Copper linen exposure
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Critically Ill

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hospital inpatients
  • Admission to intensive care unit
  • Hospital Admission at least 48 hours

Exclusion Criteria:

  • Hospital admission less than 48 hours

Sites / Locations

  • Hospital of the University of Pennsylvania
  • University of Pennsylvania School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Copper linen exposure

Non-copper linen exposure

Arm Description

Subjects will use copper linens during their hospital stay, consisting of copper hospital gowns, copper bed sheets (top and bottom sheets), and copper pillow covers. A subset of 50 subjects from this arm will be recruited to provide three types of swabs to calculate the microbial burden on copper linens. Linen swabs, anatomical swabs and environmental swabs will be collected from subjects and subject hospital rooms will be collected to do bacteria counts.

Subjects will not have exposure to copper linens during their hospital stay. They will use the usual hospital linens provided by hospital, not containing copper. A subset of 50 subjects from this arm will be recruited to provide three types of swabs to calculate the microbial burden on copper linens. Linen swabs, anatomical swabs and environmental swabs will be collected from subjects and subject hospital rooms will be collected to do bacteria counts.

Outcomes

Primary Outcome Measures

Assessment of intensive care -related hospital-acquired infections or multi-drug resistant organisms
Number of positive ICU-related MDRO cultures (Methicillin-resistant Staphylococcus aureus or MRSA, Vancomycin-resistant enterococcus or VRE, Carbapenem-resistant Enterobacteriaceae or CRE, Extended-spectrum beta-lactamase or ESBL, Clostridium difficile or C.diff)

Secondary Outcome Measures

Full Information

First Posted
December 7, 2015
Last Updated
March 6, 2023
Sponsor
University of Pennsylvania
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT02627092
Brief Title
IMPACT STUDY: Investigating Microbial Pathogen Activity of Copper Textiles
Acronym
IMPACT
Official Title
An Innovative Approach to Understanding and Controlling Transmission of HAIs
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2016 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the impact of copper linens on hospital acquired infections and drug resistant bacteria.
Detailed Description
Healthcare-associated infections (HAIs), particularly those due to multidrug-resistant organisms (MDROs), are of great clinical and public health concern. Although evidence-based prevention strategies have resulted in some success in curtailing HAIs, novel approaches are needed to achieve further reductions. Efforts to curb the emergence of MDROs have been largely unsuccessful. Thus, new strategies to address MDROs are urgently needed. This grant is comprised of two complementary studies that focus on identifying innovative approaches to more effectively prevent HAIs and curtail further emergence of MDROs. We will conduct a randomized controlled trial (RCT) to assess the efficacy of copper oxide-impregnated textiles in preventing HAIs and MDROs as well as in reducing environmental microbial contamination. We hope to provide critical information to inform the development of novel strategies, and enhance the impact of existing strategies, to successfully address HAIs and MDROs. For approximately four months the hospital is conducting a research study to learn about the possible impact of copper linens in reducing hospital acquired infections. Some rooms will have copper linens (Group 1) and some rooms will have regular linens (Group 2). The linens will be comprised of the top and bottom sheets, pillowcase cover, and hospital gown. Patients in both groups will be asked to provide samples during their stay in the ICU. For both study groups, the linens will be sampled twice after they are placed. This will occur on 2 consecutive days. At the same time, study staff will take samples from several areas of the room (the hand rails, overbed table, nurse call button). Patients will also be asked to allow the research team to obtain swabs of the nose, per-rectal area, armpit and groin. These swabs will be performed on their first day enrolled into the study, then 4 days later, and every week until ICU discharge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
424 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Copper linen exposure
Arm Type
Experimental
Arm Description
Subjects will use copper linens during their hospital stay, consisting of copper hospital gowns, copper bed sheets (top and bottom sheets), and copper pillow covers. A subset of 50 subjects from this arm will be recruited to provide three types of swabs to calculate the microbial burden on copper linens. Linen swabs, anatomical swabs and environmental swabs will be collected from subjects and subject hospital rooms will be collected to do bacteria counts.
Arm Title
Non-copper linen exposure
Arm Type
No Intervention
Arm Description
Subjects will not have exposure to copper linens during their hospital stay. They will use the usual hospital linens provided by hospital, not containing copper. A subset of 50 subjects from this arm will be recruited to provide three types of swabs to calculate the microbial burden on copper linens. Linen swabs, anatomical swabs and environmental swabs will be collected from subjects and subject hospital rooms will be collected to do bacteria counts.
Intervention Type
Other
Intervention Name(s)
Copper linen exposure
Intervention Description
Subjects will use hospital linens (top sheet, bottom sheet, pillow case, gown) made with copper to see if this helps reduce infections during their hospital stay.
Primary Outcome Measure Information:
Title
Assessment of intensive care -related hospital-acquired infections or multi-drug resistant organisms
Description
Number of positive ICU-related MDRO cultures (Methicillin-resistant Staphylococcus aureus or MRSA, Vancomycin-resistant enterococcus or VRE, Carbapenem-resistant Enterobacteriaceae or CRE, Extended-spectrum beta-lactamase or ESBL, Clostridium difficile or C.diff)
Time Frame
Duration of ICU (must be >48 hours) stay plus 2 additional hospital days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hospital inpatients Admission to intensive care unit Hospital Admission at least 48 hours Exclusion Criteria: Hospital admission less than 48 hours
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebbing Lautenbach, MD,MPH,MSCE
Organizational Affiliation
Univeristy of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pennsylvania School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No data will be shared.

Learn more about this trial

IMPACT STUDY: Investigating Microbial Pathogen Activity of Copper Textiles

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