Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2026-01-17 @ 2:26 PM
Study NCT ID:
NCT02351895
Status:
COMPLETED
Last Update Posted:
2015-08-05
First Post:
2015-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Copper Impregnated Textiles on Healthcare Associated Infections and Antibiotic Use
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003428', 'term': 'Cross Infection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1302}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-04', 'studyFirstSubmitDate': '2015-01-27', 'studyFirstSubmitQcDate': '2015-01-29', 'lastUpdatePostDateStruct': {'date': '2015-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antibiotic usage in copper impregnated vs regular linen wards >48 hours after admission to ICU', 'timeFrame': 'Two study periods of 23 weeks each', 'description': 'To assess whether the use of copper impregnated linens was associated with decreased use of antibiotics'}], 'secondaryOutcomes': [{'measure': 'Decrease in clinical infection', 'timeFrame': 'Two study periods of 23 weeks each', 'description': 'To assess whether the copper impregnated linen usage was associated with decrease in the number of clinical infections diagnosed by physicians'}, {'measure': 'Decrease in NHSN infection', 'timeFrame': 'Two study periods of 23 weeks each', 'description': 'Secondary measure included whether the copper impregnated linen usage was associated with decrease in the number of NHSN infections as defined by the infection control personnel'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['infection control', 'Prevention of hospital acquired infection'], 'conditions': ['Hospital Acquired Infection']}, 'referencesModule': {'references': [{'pmid': '23571374', 'type': 'BACKGROUND', 'citation': 'Schmidt MG, Attaway Iii HH, Fairey SE, Steed LL, Michels HT, Salgado CD. Copper continuously limits the concentration of bacteria resident on bed rails within the intensive care unit. Infect Control Hosp Epidemiol. 2013 May;34(5):530-3. doi: 10.1086/670224.'}, {'pmid': '23571364', 'type': 'BACKGROUND', 'citation': 'Salgado CD, Sepkowitz KA, John JF, Cantey JR, Attaway HH, Freeman KD, Sharpe PA, Michels HT, Schmidt MG. Copper surfaces reduce the rate of healthcare-acquired infections in the intensive care unit. Infect Control Hosp Epidemiol. 2013 May;34(5):479-86. doi: 10.1086/670207.'}, {'pmid': '12041959', 'type': 'BACKGROUND', 'citation': 'Bilian X. Intrauterine devices. Best Pract Res Clin Obstet Gynaecol. 2002 Apr;16(2):155-68. doi: 10.1053/beog.2002.0267.'}], 'seeAlsoLinks': [{'url': 'http://www.cdc.gov/nhsn/pdfs/pscmanual/17pscnosinfdef_current.pdf', 'label': 'NHSN infection definition'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective Infection Control study comparing rates of antibiotic usage and infections in the General Intensive Care Unit (GICU) in beds with copper impregnated linens versus regular linens.', 'detailedDescription': 'One ward of the ICU had copper impregnated linen while the other had regular linen. This included sheets, pillowcases, towels and patient gowns. After the first 23 week period was completed, there was a 3 week washout period. After this, the wards were switched with the first using regular linen and the second using copper impregnated linen.\n\nThe investigators followed participants and documented any infections \\>48 hours after admission to the ICU. The number and days of antibiotics used for the infections were also documented. Using assigned study numbers, the investigators obtained demographic data: age, sex, co-morbid conditions, and admitting diagnosis. All participants were followed daily in the GICU and daily for 48 hours after transfer to the regular floor. Date of discharge will be obtained retrospectively. Infection control (IC) routinely obtains Methicillin Resistant Staphylococcus Aureus (MRSA) nasal swabs on all patients on admission to the GICU, once weekly while in GICU and then again on discharge from the GICU. They monitor the GICU patients for healthcare associated infections (HAI) that meet the National Healthcare Safety Network (NHSN) 146 definitions. The NHSN is a widely used HAI tracking system, and the infections documented included Ventilator associated pneumonia (VAP), Catheter related blood stream infections (CLABSI), catheter associate urinary tract infections (CAUTI) and Clostridium difficile associated diarrhea (CDAD). They also obtain information on decubitus ulcers (bed sores) that develop during hospital stay. Infection control also routinely monitors the isolation of multi-drug resistant bacteria, namely Vancomycin Resistant Enterococci (VRE), Extended Spectrum beta Lactamase producing organisms (ESBL) and Carbapenemase producing enterobacteriaceae (CRE) as well as Multi drug resistant (MDR ) Acinetobacter baumanii from cultures. This above information will be obtained from the IC nurses on a weekly basis by the investigators.\n\nAs most of the infections in the ICU do not meet strict NHSN criteria, the investigators defined an infection as: the physician diagnosing an infection, and then initiating antibiotics for the same.\n\nCopper linen were implemented the same as regular linen. There was no difference in the nursing or physician staff on either side. No interventions were made other than existing hospital wide IC interventions'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients \\>18 years and \\<90 years who were admitted to the GICU during the study period', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:All patients \\>18 years and \\<90 years who were admitted to the GICU during the study period\n\n\\-\n\nExclusion Criteria:\n\n1. Those that did not meet the age criteria as above.\n2. Any patients with Menke's syndrome or Wilson's disease\n3. Any patient with an allergy to copper or iodine\n4. Any patient who wishes to opt out of participating"}, 'identificationModule': {'nctId': 'NCT02351895', 'briefTitle': 'Effect of Copper Impregnated Textiles on Healthcare Associated Infections and Antibiotic Use', 'organization': {'class': 'OTHER', 'fullName': 'Eastern Virginia Medical School'}, 'officialTitle': 'Effect of Copper Impregnated Textiles on Healthcare Associated Infections and Antibiotic Use in a Single Intensive Care Unit', 'orgStudyIdInfo': {'id': '13-08-FB-0171'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Copper linens', 'description': 'One ward during each period (23 weeks each) used copper impregnated linen on the bed and as patient gowns. The second ward used regular linen on the bed and as patient gowns', 'interventionNames': ['Other: Copper impregnated linen']}], 'interventions': [{'name': 'Copper impregnated linen', 'type': 'OTHER', 'description': 'Copper impregnated linen was used in place of regular linen on one ward (out of two) for each period of the study. Each study period lasted for 23 weeks. After the washout period (3 weeks) the wards were switched.', 'armGroupLabels': ['Copper linens']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Sentara Norfolk General Hospital', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Shivanjali Shankaran, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eastern Virginia Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastern Virginia Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cupron Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Internal Medicine, Division of Infectious Diseases', 'investigatorFullName': 'SShankaran', 'investigatorAffiliation': 'Eastern Virginia Medical School'}}}}