Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
Study NCT ID:
NCT06044428
Status:
COMPLETED
Last Update Posted:
2024-07-30
First Post:
2023-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Steadysense -Early Detection of Postoperative Infections Through Continuous Temperature Measurement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-29', 'studyFirstSubmitDate': '2023-08-28', 'studyFirstSubmitQcDate': '2023-09-19', 'lastUpdatePostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Temperature curve (body temperature in °C)', 'timeFrame': 'min. 5 days and max. 21 days', 'description': 'temperature curve of the Steadytemp® Patch and single routine measurements (infrared)'}, {'measure': 'wound infection or pneumonia', 'timeFrame': 'min. 5 days and max. 21 days', 'description': 'Number of patients diagnosed with wound infection or pneumonia'}], 'secondaryOutcomes': [{'measure': 'Inflammation parameter in the blood: PCT (Procalcitonin)', 'timeFrame': 'min. 5 days and max. 21 days', 'description': 'PCT (Procalcitonin) level'}, {'measure': 'Inflammation parameter in the blood: CRP (c-reactive protein)', 'timeFrame': 'min. 5 days and max. 21 days', 'description': 'CRP (c-reactive protein) level'}, {'measure': 'Inflammation parameter in the blood: Leukocytes', 'timeFrame': 'min. 5 days and max. 21 days', 'description': 'Leukocytes count'}, {'measure': 'Use of medication', 'timeFrame': 'min. 5 days and max. 21 days', 'description': 'Use of medication like antibiotics, antiphlogistics, antipyretics'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Body Temperature', 'Postoperative Infection', 'Pneumonia']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to review whether postoperative infections can be detected earlier by a continuous measurement of body temperature of patients compared to single daily measurements. Within 25 weeks 100 patients, which underwent visceral surgery less than 48h ago, will be included. A patch (Steadytemp ®) will be attached to participants, continuously measuring the body temperature. In addition infection parameters and medication of the participants will be documented.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be inpatients at the Medical University of Graz, where the need to have a visceral surgery.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* participant is willing and able to give informed consent for participation in the study\n* age 18 years and above\n* visceral surgery procedure within the last two days\n* inpatient stay on the ICIÜ (Interdisciplinary surgical intensive care unit) or normal ward\n\nExclusion Criteria:\n\n* allergy to the ingredients of skin patches\n* major psychiatric diseases including history of drug or alcohol abuse\n* chronic inflammatory disease in the medical history\n* predicted inpatient stay is less than 5 days\n* operational wound is too close to the patch adhesive site\n* the skin at the intended adhesive site of the patch is not intact\n* BMI \\> 33'}, 'identificationModule': {'nctId': 'NCT06044428', 'briefTitle': 'Steadysense -Early Detection of Postoperative Infections Through Continuous Temperature Measurement', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Steadysense -Early Detection of Postoperative Infections Through Continuous Temperature Measurement', 'orgStudyIdInfo': {'id': 'Ek-Nr.: 35-251 ex 22/23'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Steadytemp®', 'type': 'DEVICE', 'description': 'Steadytemp® is a clinical thermometer intended to continuously measure axillary temperature and to display relative changes in axillary temperature to the user. The system consists of a sensor patch and a smartphone application, the body temperature measured by the sensor is transmitted via Near-Field-Communication (NFC) and subsequently displayed in the App.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8010', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'overallOfficials': [{'name': 'Dr. Philipp Stiegler, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University Graz, Department of Surgery, Division of general, visceral and transplant surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}