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Testing Medical Device (Sensor) to detect and predict surgical site infections

An academic study of the Investigation of Digital Biomarkers for Early Detection of Surgical Site Infections

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/01/039722
Enrollment
71
Registered
2022-01-25
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

None listed

Sponsors

Crely Healthcare Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing coronary bypass surgery, between the age group 18-80 years at the time of admission

Exclusion criteria

Exclusion criteria: Subjects who are known cases of HIV

Design outcomes

Primary

MeasureTime frame
The ability of the developed sensor to collect the digital biomarkers of surgical site infection will be assessedTimepoint: Total duration of the study is 9 months from the start of study.

Secondary

MeasureTime frame
The ability of the sensor to detect an SSI will be compared with the actual diagnosis of infection by the attending clinicianTimepoint: Total duration of the study is 9 months from the start of study. Patients will be monitored with the investigational device until postoperative day 14.

Countries

India

Contacts

Public ContactDr Anusha Rohit

The Madras Medical Mission Hospital

pi.mmmhospital@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026