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CTRI Number  CTRI/2025/01/079813 [Registered on: 31/01/2025] Trial Registered Prospectively
Last Modified On: 29/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Survey of Current trends of antimicrobial prophylaxis in Orthopaedic surgeries 
Scientific Title of Study   Evaluation of current trends of antimicrobial prophylaxis in clean Orthopaedic surgeries among Orthopaedicians in India 
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 Kartik 
Designation  Junior Resident, Orthopaedics 
Affiliation  Pt. B.D. Sharma PGIMS, Rohtak 
Address  Department of Orthopaedics, Pt. B.D. Sharma PGIMS, Rohtak

Rohtak
HARYANA
124001
India 
Phone  9772439799  
Fax    
Email  kartikarora2696@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pradyumna Krishna M 
Designation  Associate Professor 
Affiliation  Pt. B.D. Sharma PGIMS, Rohtak 
Address  Department of Orthopaedics, Pt. B.D. Sharma PGIMS, Rohtak

Rohtak
HARYANA
124001
India 
Phone  7988153640  
Fax    
Email  Pradyumnakm2@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pradyumna Krishna M 
Designation  Associate Professor 
Affiliation  Pt. B.D. Sharma PGIMS, Rohtak 
Address  Department of Orthopaedics, Pt. B.D. Sharma PGIMS, Rohtak

Rohtak
HARYANA
124001
India 
Phone  7988153640  
Fax    
Email  Pradyumnakm2@gmail.com  
 
Source of Monetary or Material Support  
Material Support: Department of Orthopaedics, Pt. B.D. Sharma PGIMS Rohtak(124001) 
Monetary Support: The survey does not involve any monetary loss or gain to the surveyors or responders 
 
Primary Sponsor  
Name  Dr. Kartik 
Address  Department of Orthopaedics, PGIMS, Rohtak(124001), India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Department of Orthopaedics PGIMS Rohtak  Department of Orthopaedics, PGIMS, Rohtak(124001), India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pradyumna Krishna M  Pt. B.D. Sharma PGIMS Rohtak  Department of Orthopaedics, Pt. B.D. Sharma PGIMS, Rohtak
Rohtak
HARYANA 
7988153640

Pradyumnakm2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics Committee Pt. B.D. Sharma PGIMS Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Antimicrobial usage trends in clean Orthopaedic surgeries 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All Orthopaedic surgeons performing multidisciplinary Orthopaedic procedures with a minimum of two Orthopaedic subspecialities & working in:
Public Sector
Private Sector
Maximum three surgeons per institute 
 
ExclusionCriteria 
Details  Surgeons exclusively performing only one type of surgery(subspeciality)
Experience after post-graduation of less than 5 years
Contaminated wounds
Open fractures
Fungating tumours 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To analyse the antibiotic usage for different Orthopaedic procedures by different surgeons across the country  At Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Compare national & international trends of antibiotic usage in clean Orthopaedic surgeries & explore reasons for variation.  At baseline 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
Final Enrollment numbers achieved (Total)= "250"
Final Enrollment numbers achieved (India)="250" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/02/2025 
Date of Study Completion (India) 22/01/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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  
Surgical site infections (SSI) are associated with significant morbidity and mortality. Perioperative antibiotic prophylaxis, also frequently known as surgical antibiotic prophylaxis (SAP), is prescribed to reduce the infection risk. The choice of antimicrobial agent and its duration of administration, to an extent, remains a matter of personal choice as local community standards, bacterial resistance and local bacterial flora alter the antibiotic prophylaxis that is required.
Most elective Orthopaedic operations, including joint replacement, are categorised as clean procedures, for which the overall incidence of surgical site infection is low. Factors that increase the likelihood of infection include co-morbid systemic diseases (e.g. diabetes mellitus, rheumatoid arthritis, malignancy); postoperative wound infection; longer duration of surgery (especially over three hours); and previous arthroplasty involving the same joint.
Infections may present within the first month post-operatively or after several months or years. Early infections usually present acutely with overt deep wound infection. Late infections may manifest as increasing pain (particularly at rest), loosening of the prosthesis or sinus formation and discharge. Although the incidence of infection is highest in the first six months, up to half of all prosthetic joint infections present more than two years after the operation.
In most instances, the bacteria responsible for clinical infection of Orthopaedic implants enter the wound at the time of surgery. Such organisms can originate from the patients skin, that of the operating staff, or from circulating dust particles and skin squames in the theatre air. Much less commonly, infection of Orthopaedic implants is the result of blood-borne spread from a distant focus of infection or, even more rarely, follows a bacteraemia-prone procedure (such as bladder catheterisation). The presence of any foreign material greatly reduces the number of bacteria needed to infect the operation site. After joint replacement, the organisms responsible are often bacteria with low virulence in the absence of implanted material, such as coagulase-negative staphylococci. Infection with Staphylococcus aureus is also common, including, increasingly, methicillin-resistant Staphylococcus aureus (MRSA).
Systemic antibiotic prophylaxis in Orthopaedic implant surgeries is the standard practice of care that has been used for the last three decades.
There is enough evidence to say that prophylactic antibiotics should be used in Orthopaedics to reduce SSI. However, three controversial issues persist in the use of prophylactic antibiotics namely; (1) timing of administration (2) which antibiotics to use and (3) duration of prophylactic antibiotics.
The trend in western literature is to use second-generation cephalosporins (cefuroxime) 30 minutes to 1 hour before skin incision and preferable for 24 h to 3 days in intravenous infusion postoperatively. Cefuroxime has high bioavailability in tissue and serum after a single dose and is efficacious for preventing perioperative infection. However, in our scenario, theatre conditions and prevalent pathogens are different. Our patient population has different socioeconomic backgrounds and that cannot be compared with the developed world.
Various surgeons working in different setups (government/private) shall be contacted (in person or telephonically) and requested to fill out an electronic or physical form.
Multiple surgeons shall be contacted in person at major national/international conferences for filling out the forms.
All the data obtained from Google Forms® shall be used to populate the Google Spreadsheet® and analysed using standard statistical tools. Appropriate statistical tests shall be employed to analyse the data.
 
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