Steadysense -Early Detection of Postoperative Infections Through Continuous Temperature Measurement
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ClinicalTrials.gov Identifier: NCT06044428 |
Recruitment Status :
Recruiting
First Posted : September 21, 2023
Last Update Posted : March 13, 2024
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Condition or disease | Intervention/treatment |
---|---|
Body Temperature Postoperative Infection Pneumonia | Device: Steadytemp® |
Study Type : | Observational |
Estimated Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Steadysense -Early Detection of Postoperative Infections Through Continuous Temperature Measurement |
Actual Study Start Date : | August 14, 2023 |
Estimated Primary Completion Date : | April 2024 |
Estimated Study Completion Date : | May 2024 |
- Device: Steadytemp®
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.
- Temperature curve (body temperature in °C) [ Time Frame: min. 5 days and max. 21 days ]temperature curve of the Steadytemp® Patch and single routine measurements (infrared)
- wound infection or pneumonia [ Time Frame: min. 5 days and max. 21 days ]Number of patients diagnosed with wound infection or pneumonia
- Inflammation parameter in the blood: PCT (Procalcitonin) [ Time Frame: min. 5 days and max. 21 days ]PCT (Procalcitonin) level
- Inflammation parameter in the blood: CRP (c-reactive protein) [ Time Frame: min. 5 days and max. 21 days ]CRP (c-reactive protein) level
- Inflammation parameter in the blood: Leukocytes [ Time Frame: min. 5 days and max. 21 days ]Leukocytes count
- Use of medication [ Time Frame: min. 5 days and max. 21 days ]Use of medication like antibiotics, antiphlogistics, antipyretics
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- participant is willing and able to give informed consent for participation in the study
- age 18 years and above
- visceral surgery procedure within the last two days
- inpatient stay on the ICIÜ (Interdisciplinary surgical intensive care unit) or normal ward
Exclusion Criteria:
- allergy to the ingredients of skin patches
- major psychiatric diseases including history of drug or alcohol abuse
- chronic inflammatory disease in the medical history
- predicted inpatient stay is less than 5 days
- operational wound is too close to the patch adhesive site
- the skin at the intended adhesive site of the patch is not intact
- BMI > 33
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06044428
Contact: Dr. Philipp Stiegler, Assoc. Prof. | 004331638581181 | philipp.stiegler@medunigraz.at | |
Contact: Dickel Franziska, Dr. | 004331638583232 | franziska.dickel@medunigraz.at |
Austria | |
Medical University of Graz | Recruiting |
Graz, Austria, 8010 | |
Contact: Dr. Robert Sucher, Prof. PD 004338514094 dagmar.schloffer@medunigraz.at | |
Contact: Dr. Philipp Stiegler, Assoc. Prof. 004331638581181 philipp.stiegler@medunigraz.at |
Principal Investigator: | Dr. Philipp Stiegler, Assoc. Prof. | Medical University Graz, Department of Surgery, Division of general, visceral and transplant surgery |
Responsible Party: | Medical University of Graz |
ClinicalTrials.gov Identifier: | NCT06044428 |
Other Study ID Numbers: |
Ek-Nr.: 35-251 ex 22/23 |
First Posted: | September 21, 2023 Key Record Dates |
Last Update Posted: | March 13, 2024 |
Last Verified: | March 2024 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Infections Communicable Diseases Disease Attributes Pathologic Processes |