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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02627092
Other study ID # 822418
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2016
Est. completion date December 2023

Study information

Verified date January 2024
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 585
Est. completion date December 2023
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Hospital inpatients - Admission to intensive care unit - Hospital Admission at least 48 hours Exclusion Criteria: - Hospital admission less than 48 hours

Study Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States University of Pennsylvania School of Medicine Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pennsylvania Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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