| 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
|
|
|
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
|
|
|
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. |