Steadysense -Early Detection of Postoperative Infections Through Continuous Temperature Measurement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-14

Study Completion Date

2024-07-15

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.

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Detailed Description

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Conditions

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Body Temperature Postoperative Infection Pneumonia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No