Antibiotics in the prevention of wound infections after implant removal below the level of the knee

Phase 1

• Conditions: Surgical Site Infections; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2019-003105-10-NL

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-15
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 732

Inclusion Criteria

- Aged between 18 and 75 years
- Scheduled for IR following fracture surgery of the patella, lower leg,
ankle or foot
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 632
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

- Removing and re-implanting osteosynthetic material in the same
session
- Active wound infection or (plate) fistula
- Antibiotic treatment at time of IR for a concomitant disease or
infection
- A medical history of severe hypersensitivity to penicillin or any other
beta-lactam antibiotic
- Severe kidney insufficiency (eGFR < 35)
- Pregnancy and lactation
- Treatment with probenecid, anticoagulants (see SPC)
- Immunosuppressant use in organ transplantation or rheumatoid joint
disease
- Insufficient comprehension of the Dutch/English language to
understand the patient information to make an informed decision to
participate

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified