IMPACT STUDY: Investigating Microbial Pathogen Activity of Copper Textiles

NCT02627092 | Completed DMC

• 1 other identifier: 822418
• Study Type: interventional
• Target: 585
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to assess the impact of copper linens on hospital acquired infections and drug resistant bacteria.

Conditions

Critically Ill

Outcome Measures

Primary Outcomes (1)

• 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)

  Duration of ICU (must be >48 hours) stay plus 2 additional hospital days

Study Arms (2)

Copper linen exposure

EXPERIMENTAL

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

Non-copper linen exposure

NO INTERVENTION

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.

Interventions

Copper linen exposure OTHER

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.

Copper linen exposure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Hospital admission less than 48 hours

Sponsors & Collaborators

• University of Pennsylvania: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (2)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ebbing Lautenbach, MD,MPH,MSCE

  Univeristy of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: December 10, 2015
• Study Start: January 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)