Steadysense -Early Detection of Postoperative Infections Through Continuous Temperature Measurement

• Sponsor: Medical University of Graz (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06044428
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 6.6
• Patients Per Site Per Month: 15.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Body Temperature; Postoperative Infection; Pneumonia	Device: Steadytemp®

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Steadysense -Early Detection of Postoperative Infections Through Continuous Temperature Measurement
• Actual Study Start Date: Aug 14, 2023
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Mar 1, 2024

Outcome Measures

Primary Outcome Measures

1. Temperature curve (body temperature in °C) [min. 5 days and max. 21 days]

   temperature curve of the Steadytemp® Patch and single routine measurements (infrared)

2. wound infection or pneumonia [min. 5 days and max. 21 days]

   Number of patients diagnosed with wound infection or pneumonia

Secondary Outcome Measures

1. Inflammation parameter in the blood: PCT (Procalcitonin) [min. 5 days and max. 21 days]

   PCT (Procalcitonin) level

2. Inflammation parameter in the blood: CRP (c-reactive protein) [min. 5 days and max. 21 days]

   CRP (c-reactive protein) level

3. Inflammation parameter in the blood: Leukocytes [min. 5 days and max. 21 days]

   Leukocytes count

4. Use of medication [min. 5 days and max. 21 days]

   Use of medication like antibiotics, antiphlogistics, antipyretics

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Graz	Graz		Austria	8010

Sponsors and Collaborators

• Medical University of Graz

Investigators

• Principal Investigator: Dr. Philipp Stiegler, Assoc. Prof., Medical University Graz, Department of Surgery, Division of general, visceral and transplant surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University of Graz
• ClinicalTrials.gov Identifier: NCT06044428
• Other Study ID Numbers: Ek-Nr.: 35-251 ex 22/23
• First Posted: Sep 21, 2023
• Last Update Posted: Sep 21, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases

Study Results

No Results Posted as of Sep 21, 2023