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Does Extended Antibiotic Prophylaxis reduce infection rates in Total Joint Arthroplasty?

A Randomized Control Trial Evaluating the Efficacy of Extended Antibiotic Prophylaxis in Total Joint Arthroplasty for the Prevention of Surgical Site Infections - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/067178
Enrollment
2000
Registered
2024-05-10
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: 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,

Sponsors

KIMS Sunshine Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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 Timepoint: 2 weeks, 4 weeks, 8 weeks, 12 weeks

Secondary

MeasureTime frame
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 Timepoint: 2 weeks, 4 weeks, 8 weeks, 12 weeks

Countries

India

Contacts

Public ContactRonak Kothari

Sunshine Bone and Joint Institute, KIMS - Sunshine Hospitals

ronakkothari1208@gmail.com9987951519

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026