Steadysense -Early Detection of Postoperative Infections Through Continuous Temperature Measurement

Study Overview
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Brief Summary
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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.

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

Conditions
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Body Temperature, Postoperative Infection, Pneumonia

Intervention / Treatment
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* Device: Steadytemp®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temperature curve (body temperature in °C) | temperature curve of the Steadytemp® Patch and single routine measurements (infrared) | min. 5 days and max. 21 days | 
| wound infection or pneumonia | Number of patients diagnosed with wound infection or pneumonia | min. 5 days and max. 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation parameter in the blood: PCT (Procalcitonin) | PCT (Procalcitonin) level | min. 5 days and max. 21 days | 
| Inflammation parameter in the blood: CRP (c-reactive protein) | CRP (c-reactive protein) level | min. 5 days and max. 21 days | 
| Inflammation parameter in the blood: Leukocytes | Leukocytes count | min. 5 days and max. 21 days | 
| Use of medication | Use of medication like antibiotics, antiphlogistics, antipyretics | min. 5 days and max. 21 days |