| 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
|
|
|
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. |