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Clinical Trials/CTRI/2025/09/094961
CTRI/2025/09/094961
Not yet recruiting
Not Applicable

A prospective longitudinal study on perioperative antimicrobial use pattern for elective surgeries in Orthopedics and General Surgery in a tertiary care hospital

IPGMER and SSKM Hospital1 site in 1 country320 target enrollmentStarted: October 1, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
IPGMER and SSKM Hospital
Enrollment
320
Locations
1
Primary Endpoint
To assess perioperative antimicrobial prescribing pattern in selected elective surgeries conducted in the departments of General Surgery and Orthopedics

Overview

Brief Summary

This is a prospective longitudinal study which aims to assess perioperative antimicrobial prescribing patterns in elective orthopedics and general surgeries at a tertiary hospital in West Bengal. It evaluates adherence to local and national guidelines. It will help to identify the incidence of surgical site infections (SSIs). Despite existing protocols recommending limited prophylactic use, inappropriate and prolonged antimicrobial use remains widespread in India. This leads to antimicrobial resistance and increased duration of hospitalization and healthcare costs. The study will include around 320 adult patients undergoing common elective surgeries of the hospital. This will have data based on their demographics, clinical history, antimicrobial use and possible outcomes. Statistical analysis will further help to identify possible deviations and inform better antimicrobial stewardship practices.

Almost all studies have mentioned that significant deviation has been noted in real world scenario from recommended guidelines. Therefore further research and audit are needed to understand the lacunae. Though inappropriate usage of antimicrobials in peri-operative procedures is a serious matter of concern there is paucity of studies regarding this in India. Therefore we have undertaken this prospective longitudinal study to evaluate the pattern of peri-operative antimicrobial prophylaxis.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 80.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients scheduled for elective surgeries.
  • Orthopaedics total knee replacement hip replacement arthroplasty.
  • General surgery laparoscopic cholecystectomy hernia repair.

Exclusion Criteria

  • Any emergency surgeries Any elective surgeries except the listed.

Outcomes

Primary Outcomes

To assess perioperative antimicrobial prescribing pattern in selected elective surgeries conducted in the departments of General Surgery and Orthopedics

Time Frame: Day 0 to Day 14 | from admission to outcome

Secondary Outcomes

  • To identify deviations (if any) in the antimicrobial usage pattern from local and national guidelines. To estimate frequency of postoperative infections during hospital stay in the study cohort

Investigators

Sponsor
IPGMER and SSKM Hospital
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Pratik Basu

IPGMER and SSKM HOSPITAL

Study Sites (1)

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