Critically IllIMPACTNCT02627092
IMPACT STUDY: Investigating Microbial Pathogen Activity of Copper Textiles
A study testing Copper linen exposure in people with Critically Ill, run by University of Pennsylvania at 2 sites in United States.
Trial summary
The purpose of this study is to assess the impact of copper linens on hospital acquired infections and drug resistant bacteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill
- What is being tested?
- Copper linen exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 585 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2016to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospital inpatients
- Admission to intensive care unit
- Hospital Admission at least 48 hours
Who cannot join
- Hospital admission less than 48 hours
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104
About this study
Official title: An Innovative Approach to Understanding and Controlling Transmission of HAIs
The purpose of this study is to assess the impact of copper linens on hospital acquired infections and drug resistant bacteria.
Read the 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.
- Conditions
- Critically Ill
- Being tested
- Copper linen exposure
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copper linen exposureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Duration of ICU (must be >48 hours) stay plus 2 additional hospital days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionAug 2016
- Study completionDec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 585 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Ebbing Lautenbach, MD,MPH,MSCE, Principal investigator, Univeristy of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627092
- Sponsor's protocol ID
- 822418
- Acronym
- IMPACT
- Status last verified
- Jan 2024
- First submitted
- 7 Dec 2015
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative Approach to Understanding and Controlling Transmission of HAIs
- ClinicalTrials.gov ID
- NCT02627092
- Acronym / sponsor ID
- IMPACT / 822418
- Conditions
- Critically Ill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 585 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Jan 2016 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 10 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Copper linen exposure | Experimental | Other: Copper linen exposureSubjects 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 | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hospital inpatients
- Admission to intensive care unit
- Hospital Admission at least 48 hours
Key exclusion criteria (1 listed)
- Hospital admission less than 48 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Copper linen exposureSubjects 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 | Copper linen exposure |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No. No data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebbing Lautenbach, MD,MPH,MSCE principal investigator
Univeristy of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Copper linen exposure in people with Critically Ill, run by University of Pennsylvania at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.