| CTRI Number |
CTRI/2024/05/067178 [Registered on: 10/05/2024] Trial Registered Prospectively |
| Last Modified On: |
10/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Does Extended Antibiotic Prophylaxis reduce infection rates in Total Joint Arthroplasty? |
|
Scientific Title of Study
|
A Randomized Control Trial Evaluating the Efficacy of Extended Antibiotic Prophylaxis in Total Joint Arthroplasty for the Prevention of Surgical Site 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 Tarun Jayakumar |
| Designation |
Consultant |
| Affiliation |
Sunshine Bone and Joint Institute, KIMS - Sunshine Hospitals |
| Address |
Dept of Orthopaedics, 1st floor
KIMS - Sunshine Hospitals, Metro Pillar No. C1327, beside Jamia Masjid, Prakash Nagar, Begumpet, Hyderabad, Telangana 500016
Hyderabad
TELANGANA
500016
India |
| Phone |
9663365766 |
| Fax |
|
| Email |
tarunjaykumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ronak Kothari |
| Designation |
Fellow |
| Affiliation |
Sunshine Bone and Joint Institute, KIMS - Sunshine Hospitals |
| Address |
Dept. of Orthopaedics, 1st floor
KIMS - Sunshine Hospitals, Metro Pillar No. C1327, beside Jamia Masjid, Prakash Nagar, Begumpet, Hyderabad, Telangana 500016
Hyderabad
TELANGANA
500016
India |
| Phone |
9987951519 |
| Fax |
|
| Email |
ronakkothari1208@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ronak Kothari |
| Designation |
Fellow |
| Affiliation |
Sunshine Bone and Joint Institute, KIMS - Sunshine Hospitals |
| Address |
Dept. of Orthopaedics, 1st floor
KIMS - Sunshine Hospitals, Metro Pillar No. C1327, beside Jamia Masjid, Prakash Nagar, Begumpet, Hyderabad, Telangana 500016
TELANGANA
500016
India |
| Phone |
9987951519 |
| Fax |
|
| Email |
ronakkothari1208@gmail.com |
|
|
Source of Monetary or Material Support
|
| KIMS-Sunshine Hospital, Hyderabad |
|
|
Primary Sponsor
|
| Name |
KIMS Sunshine Hospital |
| Address |
Metro Pillar No. C1327, beside Jamia Masjid, Prakash Nagar, Begumpet, Hyderabad, Telangana 500016 |
| Type of Sponsor |
Other [NIL] |
|
|
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 Tarun Jayakumar |
KIMS-Sunshine Hospital |
Dept. of Orthopaedics, 1st floor,
Metro Pillar No. C1327, beside Jamia Masjid, Prakash Nagar, Begumpet, Hyderabad, Telangana 500016
Hyderabad
TELANGANA |
9663365766
tarunjaykumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee, KIMS-Sunshine Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Extended Oral antibiotic for 7 days |
Extended prophylaxis: This involves administering oral antibiotics for longer than 24 hours, for 7 days.
Third generation cephalosporin (Cefdinir, 300mg) BD for 7 days.
|
| Comparator Agent |
Standard perioperative antibiotic prophylaxis (Control group) |
Standard prophylaxis: This usually involves a single dose of antibiotic (Cefuroxime, 1.5g) given intravenously before surgery and continued for 24 hours (3 doses total) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing primary total hip and total knee arthroplasty.
2. Age between 18 and 80 years
3. No known contraindications to extended antibiotic use like allergy or hypersensitivity.
|
|
| ExclusionCriteria |
| Details |
1. Known allergy to Cephalosporins/Doxycycline.
2. History of recent systemic/ local infection
3. Concurrent systemic infections
4. h/o previous knee/ hip surgeries.
5. h/o prior intra-articular injections within 3 months
6. Inflammatory, post-traumatic arthritis
7. Patients on immune-suppressive medications including anti-cancer drugs, and steroids.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome:
1. Incidence of PJI and surgical site infections within the 90-day postoperative period- based on 2018 MSIS- ICM criteria
2. Incidence of Surgical Site Infection
3. Incidence of Reoperation- due to any cause
4. Incidence of stitch abscess
|
2 weeks, 4 weeks, 8 weeks, 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcomes:
Need for repeat oral antibiotic within follow-up duration
Types of pathogens causing infections
Rates of antibiotic resistance among isolated pathogens
Adverse effects related to extended antibiotic use
|
2 weeks, 4 weeks, 8 weeks, 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="2000"
Sample Size from India="2000"
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)
|
27/05/2024 |
| 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)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Introduction: · Surgical site infections (SSIs) are persistent concerns in total joint arthroplasty (TJA). · While antibiotic prophylaxis is crucial, the optimal duration remains controversial. · This randomized controlled trial (RCT) aims to assess the efficacy of oral extended antibiotic prophylaxis in TJA for preventing SSIs when compared to the routine standard protocol. · This study seeks to provide evidence for optimizing perioperative care, reducing SSIs and enhancing patient outcomes in knee arthroplasty surgery. By addressing this clinical conundrum, we hope to contribute valuable insights to perioperative protocols and ultimately improve the quality of care for TJA patients. Aims and Objectives: • To investigate whether extending the duration of oral antibiotic prophylaxis for 7 days in Total Joint arthroplasty - Hip and Knee reduces the incidence of peri-prosthetic joint infections (PJI) & surgical site infections (Test group) compared to standard perioperative antibiotic prophylaxis (Control group). Objectives: • To assess 90-day complication and readmission rates among both cohorts. • Wound complications in both cohorts. • Need for repeat oral antibiotic within follow-up duration. • Rates of antibiotic resistance among isolated pathogens. • Adverse effects related to extended antibiotic use. HYPOTHESIS: There is no difference in the incidence of peri-prosthetic joint infections (PJI) & surgical site infections on extending the duration of oral antibiotic prophylaxis for 7 days in Total joint arthroplasty compared to standard perioperative antibiotic prophylaxis. |