Trial | NCT02225821  Report issue

Title

Wound Infections Following Implant Removal
Antibiotic Prophylaxis to Prevent Wound Infections Following Implant Removal

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    500
In the Netherlands about 18,000 surgical procedures with implant removal are annually performed after fracture healing, of which 30-80% concern the foot, ankle and lower leg region. For clean surgical procedures, the rate of postoperative wound infections (POWIs) should be less than 5%. However, rates of 10-12% following implant removal, specifically after foot, ankle and lower leg fractures are reported. Currently, surgeons decide individually if antibiotics prophylaxis is given, since no guideline exists. This leads to undesirable practice variation.

Therefore, the investigators propose a double-blind randomized controlled trial (RCT) in patients scheduled for implant removal following a foot, ankle or lower leg fracture, to assess the (cost-)effectiveness of a single gift of antibiotic prophylaxis. Primary outcome is a POWI within 30 days after implant removal. Secondary outcomes are quality of life, functional outcome at 30 days and 6 months after implant removal and costs.

With 2 x 250 patients a decrease in POWI from 10% to 3.3% (expected rate in clean-contaminated elective orthopedic trauma procedures) can be detected (Power=80%, 2-sided alpha=5%, including 15% lost to follow up).

If the assumption of the investigators, that prophylactic antibiotics prior to implant removal reduces the infectious complication rate, is confirmed by this RCT, this will offer a strong argument to adopt a single gift of antibiotic prophylaxis as standard practice of care. This will reduce the incidence of POWIs and consequently will lead to less physical and social disabilities and health care use. In addition, it will decrease the rate of use of empiric broad-spectrum antibiotics (and antibiotic resistance) prescribed upon suspicion or diagnosis of a POWI. A preliminary, conservative estimation suggests yearly cost savings in the Netherlands of €3.5 million per year.
See study protocol
Study Started
Nov 30
2014
Primary Completion
Nov 30
2016
Study Completion
Nov 30
2016
Last Update
Dec 22
2016
Estimate

Drug Cephalozin

1000 mg Cephalozin

  • Other names: Kefzol

Other Sodium chloride

10 cc of NaCl 0.9%

  • Other names: NaCl 0.9%

antibiotic prophylaxis Active Comparator

a single gift of 1000 mg cefazolin in 10 cc of NaCl 0.9% (intervention group)

No antibiotic prophylaxis Placebo Comparator

a single gift of 10 cc NaCl 0.9%, given in the same manner (control group).

Criteria 

Inclusion Criteria:

Patients ≥18 years and ≤75 years of all ethnic backgrounds
Implant removal following foot, ankle and/or lower leg surgery

Exclusion Criteria:

Removing and re-implanting osteosynthesis material in the same session
Active wound infection or (plate) fistula
Antibiotic treatment at time of elective implant removal for a concomitant disease or infection
A medical history of an allergic reaction to a cephalosporin, penicillin, or any other β-lactam antibiotic.
Insufficient comprehension of the Dutch language to understand the patient information to make an informed decision to participate.
Kidney disease (eGFR <60 ml/min/1.73m^2).
Treatment with probenecide, anticoagulants (see SPC)
Pregnancy and lactation
No Results Posted