A Randomized Control Trial Evaluating the Efficacy of Extended Antibiotic Prophylaxis in Total Joint Arthroplasty for the Prevention of Surgical Site Infections
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 2,000
- Locations
- 1
- Primary Endpoint
- Primary Outcome:
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Double
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients undergoing primary total hip and total knee arthroplasty.
- •Age between 18 and 80 years
- •No known contraindications to extended antibiotic use like allergy or hypersensitivity.
Exclusion Criteria
- •Known allergy to Cephalosporins/Doxycycline.
- •History of recent systemic/ local infection
- •Concurrent systemic infections
- •h/o previous knee/ hip surgeries.
- •h/o prior intra-articular injections within 3 months
- •Inflammatory, post-traumatic arthritis
- •Patients on immune-suppressive medications including anti-cancer drugs, and steroids.
Outcomes
Primary Outcomes
Primary Outcome:
Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks
1. Incidence of PJI and surgical site infections within the 90-day postoperative period- based on 2018 MSIS- ICM criteria
Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks
2. Incidence of Surgical Site Infection
Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks
3. Incidence of Reoperation- due to any cause
Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks
4. Incidence of stitch abscess
Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks
Secondary Outcomes
- Secondary Outcomes:(Need for repeat oral antibiotic within follow-up duration)
Investigators
Dr Tarun Jayakumar
Sunshine Bone and Joint Institute, KIMS - Sunshine Hospitals