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CTRI Number  CTRI/2025/09/094961 [Registered on: 17/09/2025] Trial Registered Prospectively
Last Modified On: 16/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective longitudinal 
Study Design  Single Arm Study 
Public Title of Study   A study to analyze use of antibiotics in planned surgeries of Orthopedics and General Surgery 
Scientific Title of Study   A prospective longitudinal study on perioperative antimicrobial use pattern for elective surgeries in Orthopedics and General Surgery in a tertiary care hospital 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pratik Basu 
Designation  Junior Resident Pharmacology 
Affiliation  IPGMER and SSKM HOSPITAL 
Address  Department of Pharmacology, UCM building, 1st floor,IPGMER and SSKM HOSPITAL, 244 B AJC Bose Road. Bhowanipore Kolkata
244 AJC Bose Road. Bhowanipore . Kolkata
Kolkata
WEST BENGAL
700020
India 
Phone  22041371  
Fax    
Email  iampratik80@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suparna Chatterjee 
Designation  Professor 
Affiliation  IPGMER and SSKM HOSPITAL 
Address  Department of Pharmacology, UCM building, 1st floor,IPGMER and SSKM HOSPITAL, 244 AJC Bose Road. Bhowanipore . Kolkata
244B AJC Bose Road. Bhowanipore . Kolkata2
Kolkata
WEST BENGAL
700020
India 
Phone  22041371  
Fax    
Email  drsupchat@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Suparna Chatterjee 
Designation  Professor 
Affiliation  IPGMER and SSKM HOSPITAL 
Address  Department of Pharmacology, UCM building, 1st floor,IPGMER and SSKM HOSPITAL, 244 AJC Bose Road. Bhowanipore . Kolkata
244B AJC Bose Road. Bhowanipore . Kolkata2
Kolkata
WEST BENGAL
700020
India 
Phone  22041371  
Fax    
Email  drsupchat@gmail.com  
 
Source of Monetary or Material Support  
Department of Pharmacology, UCM building, 1st floor,IPGMER and SSKM HOSPITAL, IPGMER AJC BOSE ROAD Kolkata 700020 India intramural funds 
 
Primary Sponsor  
Name  IPGMER and SSKM Hospital 
Address  Department of Pharmacology, UCM building, 1st floor,IPGMER and SSKM HOSPITAL, 244B AJC Bose Road. Bhowanipore . Kolkata 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pratik Basu  IPGMER and SSKM HOSPITAL  In patient ward of Orthopedics and General Surgery
Kolkata
WEST BENGAL 
07001686334

iampratik80@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IPGMER Reasearch Oversight Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K812||Acute cholecystitis with chronic cholecystitis, (2) ICD-10 Condition: K40-K46||Hernia, (3) ICD-10 Condition: M16||Osteoarthritis of hip, (4) ICD-10 Condition: M17||Osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients scheduled for elective surgeries.
Orthopaedics total knee replacement hip replacement arthroplasty.
General surgery laparoscopic cholecystectomy hernia repair.
 
 
ExclusionCriteria 
Details  Any emergency surgeries

Any elective surgeries except the listed  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess perioperative antimicrobial prescribing pattern in selected elective surgeries conducted in the departments of General Surgery and Orthopedics
 
Day 0 to Day 14
from admission to outcome
 
 
Secondary Outcome  
Outcome  TimePoints 
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
 
18 months 
 
Target Sample Size   Total Sample Size="320"
Sample Size from India="320" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.

 
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