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.
