Wound Infections Following Implant Removal (WIFI)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status and phase

Completed

Phase 4

Conditions

Surgical Wound Infection

Treatments

Drug: Cephalozin

Other: Sodium chloride

Study type

Interventional

Funder types

Other

Identifiers

NCT02225821

NTR 4393 (Other Identifier)

SB155014

Details and patient eligibility

About

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.

Full description

See study protocol

Enrollment

500 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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