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Steadysense -Early Detection of Postoperative Infections Through Continuous Temperature Measurement

Steadysense -Early Detection of Postoperative Infections Through Continuous Temperature Measurement

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06044428
Enrollment
103
Registered
2023-09-21
Start date
2023-08-14
Completion date
2024-07-15
Last updated
2024-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Temperature, Pneumonia, Postoperative Infection

Brief 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.

Interventions

DEVICESteadytemp®

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.

Sponsors

Medical University of Graz
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Temperature curve (body temperature in °C)min. 5 days and max. 21 daystemperature curve of the Steadytemp® Patch and single routine measurements (infrared)
wound infection or pneumoniamin. 5 days and max. 21 daysNumber of patients diagnosed with wound infection or pneumonia

Secondary

MeasureTime frameDescription
Inflammation parameter in the blood: PCT (Procalcitonin)min. 5 days and max. 21 daysPCT (Procalcitonin) level
Inflammation parameter in the blood: CRP (c-reactive protein)min. 5 days and max. 21 daysCRP (c-reactive protein) level
Inflammation parameter in the blood: Leukocytesmin. 5 days and max. 21 daysLeukocytes count
Use of medicationmin. 5 days and max. 21 daysUse of medication like antibiotics, antiphlogistics, antipyretics

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026