Steadysense -Early Detection of Postoperative Infections Through Continuous Temperature Measurement

Completed

• Conditions: Body Temperature; Pneumonia; Postoperative Infection

• Registration Number: NCT06044428
• Lead Sponsor: Medical University of Graz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-14
• Study First Submitted: 2023-08-28
• Study First Submitted QC: 2023-09-19
• Study First Posted: 2023-09-21
• Primary Completion: 2024-05-30
• Status Verified: 2024-07
• Study Completion: 2024-07-15
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria