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Testing a Medical Device to predict surgical site infection

Pre-Pilot Study of Digital Biomarkers to detect Surgical Site Infection Post-Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/02/031351
Enrollment
30
Registered
2021-02-17
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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 Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients undergoing open abdominal surgeries between the ages of 18 to 80 years 2. ASA I to II

Exclusion criteria

Exclusion criteria: 1. Patients who require preoperative oxygen supplementation 2. Patients who need continuous postoperative oxygenation and ventilatory requirements 3. Patients whose primary wound closure could not be performed 4. Patients with severe COPD

Design outcomes

Secondary

MeasureTime frame
The ability of the developed sensor would be compared with the gold standard device InspectraTimepoint: Total duration is 4 months from start of study. Patients will be monitored with the investigational device till POD5—

Primary

MeasureTime frame
The ability of the developed sensor to predict surgical site infection as early as possible would be tested in 30 patients who undergo open abdominal surgeriesTimepoint: Total duration is 4 months from start of study. Patients will be monitored with the investigational device till POD5—

Countries

India

Contacts

Public ContactDr Meena Iyer

Sri Ramachandra Institute of Higher Education and Research (SRIHER)

srmcclinicalresearch@gmail.com9841330590

Outcome results

None listed

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