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Early detection Of post-operative infection after abdominal surgery

An academic study of the investigation of digital biomarkers for early detection of surgical site infections - Nil

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/058027
Enrollment
200
Registered
2023-09-26
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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

Intervention1: Algorithm based post-operative risk index: This study will be conducted as a prospective randomized controlled trial. Patients will be randomized to either the intervention arm (based o
physiological data collected as a part of their routine procedure 3. Complete physical examination will be performed to preclude any local or systemic infections. Standard pre-operative procedure will

Sponsors

Madras Medical College
Lead Sponsor
Crely Healthcare Private Limited
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients who are undergoing elective or emergency laparotomy or undergoing gastrointestinal surgery for benign and malignant conditions 2.18-80 years of age at the time of admission

Exclusion criteria

Exclusion criteria: 1.Subjects who are diagnosed of communicable diseases and are a risk for biohazard 2.Subjects with preoperative sepsis

Design outcomes

Primary

MeasureTime frame
To collect objective and quantifiable digital biomarker data continuously from the surgical site of patients who have undergone elective or emergency laparotomy, to develop early warning algorithms to detect and predict the likelihood of SSIsTimepoint: Day of Surgery to 30 days post-discharge

Secondary

MeasureTime frame
Remotely monitor the surgical wound during the post-operative period using a novel medical deviceTimepoint: Day of Surgery to Discharge from hospital

Countries

India

Contacts

Public ContactPROF DR PS SHANTHI MS

Institute of General Surgery

hugvikas@hotmail.com8920984970

Outcome results

None listed

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