Steadysense -Early Detection of Postoperative Infections Through Continuous Temperature Measurement

NCT06044428 | Completed

• 1 other identifier: Ek-Nr.: 35-251 ex 22/23
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Temperature; Postoperative Infection; Pneumonia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Inflammation parameter in the blood: PCT (Procalcitonin)

  min. 5 days and max. 21 days

• Inflammation parameter in the blood: CRP (c-reactive protein)

  min. 5 days and max. 21 days

• Inflammation parameter in the blood: Leukocytes

  min. 5 days and max. 21 days

• Use of medication

  min. 5 days and max. 21 days

Interventions

Steadytemp® DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants will be inpatients at the Medical University of Graz, where the need to have a visceral surgery.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, 8010, Austria

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dr. Philipp Stiegler, Assoc. Prof.

  Medical University Graz, Department of Surgery, Division of general, visceral and transplant surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 21, 2023
• Study Start: August 14, 2023
• Primary Completion: May 30, 2024
• Study Completion: July 15, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

AU (1)