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NCT06044428 Clinical Trial

Steadysense -Early Detection of Postoperative Infections Through Continuous Temperature Measurement

Pneumonia Clinical Trial

Official title:
Steadysense -Early Detection of Postoperative Infections Through Continuous Temperature Measurement

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06044428
Other study ID # Ek-Nr.: 35-251 ex 22/23
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 14, 2023
Est. completion date May 2024

Study information
Verified date March 2024
Source Medical University of Graz
Contact Dr. Philipp Stiegler, Assoc. Prof.
Phone 004331638581181
Email philipp.stiegler@medunigraz.at
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date May 2024
Est. primary completion date April 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Austria Medical University of Graz Graz

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Temperature curve (body temperature in °C) temperature curve of the Steadytemp® Patch and single routine measurements (infrared) min. 5 days and max. 21 days
Primary wound infection or pneumonia Number of patients diagnosed with wound infection or pneumonia min. 5 days and max. 21 days
Secondary Inflammation parameter in the blood: PCT (Procalcitonin) PCT (Procalcitonin) level min. 5 days and max. 21 days
Secondary Inflammation parameter in the blood: CRP (c-reactive protein) CRP (c-reactive protein) level min. 5 days and max. 21 days
Secondary Inflammation parameter in the blood: Leukocytes Leukocytes count min. 5 days and max. 21 days
Secondary Use of medication Use of medication like antibiotics, antiphlogistics, antipyretics min. 5 days and max. 21 days
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