| CTRI Number |
CTRI/2024/04/065612 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
11/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To Assess the Efficiency of local Application of Vancomycin powder, alongside standard intravenous antibiotics in patients undergoing Total Hip and Knee Replacement surgeries through a Randomized Controlled Trial. |
|
Scientific Title of Study
|
Randomized Controlled Trial of Intrawound application of Vancomycin powder in Total Hip and Knee Arthroplasty as compared with standard postoperative antibiotics in preventing postoperative infections. |
| 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 Boopathy M |
| Designation |
Junior Resident |
| Affiliation |
JSS Medical College and Hospital, Mysore |
| Address |
Department of Orthopaedics,
JSS Medical College and Hospital, Mysuru.
Mysore
KARNATAKA
570015
India |
| Phone |
9487584771 |
| Fax |
|
| Email |
boopathy4868@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddalingamurthy G |
| Designation |
Professor and Head |
| Affiliation |
JSS Medical College and Hospital, Mysore |
| Address |
Department of Orthopaedics,
JSS Medical College and Hospital, Mysore
Mysore
KARNATAKA
570015
India |
| Phone |
9901273360 |
| Fax |
|
| Email |
siddalingamurthyg@jssuni.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Siddalingamurthy G |
| Designation |
Professor and Head |
| Affiliation |
JSS Medical College and Hospital, Mysore |
| Address |
Department of Orthopaedics,
JSS Medical College and Hospital, Mysore
Mysore
KARNATAKA
570015
India |
| Phone |
9901273360 |
| Fax |
|
| Email |
siddalingamurthyg@jssuni.edu.in |
|
|
Source of Monetary or Material Support
|
| JSS Hospital and Medical College,Mahathma Gandhi Road, Mysuru - 570 004, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
JSS Academy of Higher Education and Research |
| Address |
Mahatma Gandhi Road, Fort Mohalia, Mysuru, karnataka-570004 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Boopathy M |
JSS Medical College and Hospital |
Department of Orthopaedics,
JSS medical College and Hospital, Mysore
Mysore
KARNATAKA |
9487584771
boopathy4868@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, JSS Medical College and Hospital, Mysore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group:
Patients are given only standard postoperative antibiotics. |
Patient in control group is given only standard posoperative antibiotics(IV antibiotics followed by Oral antibiotics).The patient is followed up for a total period of 1 year and monitored for Surgical Site Infection, Periprosthetic Joint Infection and Osteomyelitis. |
| Intervention |
Trial Group: Intrawound Application of Vancomycin along with postoperative antibiotics |
1 gram of Vancomycin is mixed with Normal saline and used for surgical site lavage and 1 gram of Vancomycin powder is applied directly in the wound before closure in the vancomycin group in patients undergoing Total Hip and Knee Arthroplasty in addition to standard postoperative antibiotics.The patient is followed up for a total period of 1 year and monitored for Surgical Site Infection, Periprosthetic Joint Infection and Osteomyelitis. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All individuals aged 18 years or older who have been admitted in JSS Hospital, Mysuru and are undergoing elective THR, TKR will be used.
|
|
| ExclusionCriteria |
| Details |
1) Patients with sepsis, hemodynamic instability or displayed signs of active infection(septic arthritis)
2)Patients with a known allergy to Vancomycin (itchiness, swelling, anaphylactic reaction).
3)Patients undergoing revision THR and Revision TKR.
4)Patients who are immunocompromised.
5)Patients who had previous surgery or history of radiation therapy at the surgical site.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of local application of Vancomycin powder in preventing Surgical Site Infections in patients undergoing Total Hip Replacement and Total Knee Replacement Surgeries |
The time points during which the patients would be assessed are preoperatively, postoperative period (2nd, 5th and tenth day), 2nd week, 6th week, 3rd month, 6th month and 1 year after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the adverse effects of intrawound application of Vancomycin Powder |
Postopertive period, 2nd week, 6th week, 3rd month, 6th month and 1 year after surgery. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
22/04/2024 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - Data requestors will need to sign a data access agreement and proposals to be sent to the email ID boopathy4868@gmail.com
- For how long will this data be available start date provided 01-08-2026 and end date provided 01-08-2036?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Following approval from the Institutional Ethical Committee, All Patients admitted in JSS hospital, Department of Orthopaedics, Mysuru above the age of 18 years who will undergo Total Hip Replacement and Total Knee Replacement. After acquiring written, informed consent, Patients will be assessed by a Performa consisting of a series of questions that will contain the necessary information such as patient demographic information such as Age, Sex, Body Mass Index, ASA Classification, diabetes, hemoglobin levels, smoking and alcohol consumption, acute liver disease etc. Patients who fulfill the inclusion criteria will be taken up for study and after written informed consent, the patient will be randomized into two groups depending upon the local application of Vancomycin powder. 1 gram of Vancomycin is mixed with Normal saline and used for surgical site lavage and 1 gram of Vancomycin powder is applied directly in the wound before closure in the vancomycin group.the Vancomycin group is also given standard post operative antibiotics(Cefuroxime 1.5g). The control group will receive standard post operative antibiotics(Cefuroxime1.5g). Both the groups will be followed for 1 year after the procedure for post operative infections. Post operatively, patients will be monitored for signs of infection in the early postoperative period, 2 weeks, 6 weeks, 3 months, 6 months and 1 year by clinical examination, radiological, microbiological and blood investigations if necessary. At the end of study period, both the groups will be statistically compared to come to a conclusion based on the data obtained from the study. |