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.
Phase:
Phase 4
Details
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators:
AO Research Fund ZonMw: The Netherlands Organisation for Health Research and Development