Clinical trial NCT02627092: IMPACT STUDY: Investigating Microbial Pathogen Activity of Copper Textiles
Official title: An Innovative Approach to Understanding and Controlling Transmission of HAIs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critically Ill
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2015-12-10
Enrollment: 585
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Assessment of intensive care -related hospital-acquired infections or multi-drug resistant organisms
timeFrame: Duration of ICU (must be >48 hours) stay plus 2 additional hospital days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania School of Medicine
state: Pennsylvania
Study officials:
affiliation: Univeristy of Pennsylvania
name: Ebbing Lautenbach, MD,MPH,MSCE
role: PRINCIPAL_INVESTIGATOR
References: