IMPACT STUDY: Investigating Microbial Pathogen Activity of Copper Textiles

ID: NCT02627092
Status: Active, not recruiting
Phase: N/A
Start Date: January 01, 2016
First Submitted: December 07, 2015
Last Updated: February 05, 2018
Results: N/A
Sponsors & Collaborators: University of Pennsylvania, Centers for Disease Control and Prevention
Location: United States
Conditions: Critically Ill
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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.
Condition or disease Intervention/treatment Phase

Critically Ill

Other: Copper linen exposure
Other Names
N/A

Tracking Information

First Submitted DateDecember 07, 2015
Last Update Posted DateFebruary 05, 2018
Actual Start DateJanuary 01, 2016
Anticipated Completion DateApril 01, 2018
Actual Primary Completion DateAugust 01, 2016
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Assessment of intensive care -related hospital-acquired infections or multi-drug resistant organisms [Time Frame: Duration of ICU (must be >48 hours) stay plus 2 additional hospital days]

    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)

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleIMPACT STUDY: Investigating Microbial Pathogen Activity of Copper Textiles
Official TitleAn Innovative Approach to Understanding and Controlling Transmission of HAIs
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.

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
424
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
None (Open Label)
Primary Purpose
Prevention
Conditions
Critically Ill
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Other: Copper linen exposure

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.

Other Names
Study Groups/Cohorts
Copper linen exposure
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.

Non-copper linen exposure
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.

Study Arms
Experimental Copper linen exposure
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.
Other : Copper linen exposure
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.

Arm Intervention/Treatment
Experimental Copper linen exposure
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.
Other : Copper linen exposure

Recruitment Information

Recruitment Status:Active, not recruiting
Enrollment424
Completion DateApril 01, 2018
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
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT02627092
Other Study ID Numbers
822418
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
University of Pennsylvania
Collaborators
Centers for Disease Control and Prevention
Investigators
Principal Investigator
Ebbing Lautenbach, MD,MPH,MSCE
Univeristy of Pennsylvania