Wound Infections Following Implant Removal (WIFI)
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|ClinicalTrials.gov Identifier: NCT02225821|
Recruitment Status : Completed
First Posted : August 26, 2014
Last Update Posted : December 22, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Surgical Wound Infection||Drug: Cephalozin Other: Sodium chloride||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Antibiotic Prophylaxis to Prevent Wound Infections Following Implant Removal|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
Active Comparator: antibiotic prophylaxis
a single gift of 1000 mg cefazolin in 10 cc of NaCl 0.9% (intervention group)
1000 mg Cephalozin
Other Name: Kefzol
Placebo Comparator: No antibiotic prophylaxis
a single gift of 10 cc NaCl 0.9%, given in the same manner (control group).
Other: Sodium chloride
10 cc of NaCl 0.9%
Other Name: NaCl 0.9%
- Postoperative wound infection (POWI) [ Time Frame: 30 days ]The primary outcome variable is a POWI within 30 days after implant removal as defined by the criteria applied by the Centers for Disease and Control.
- Health-related quality of life [ Time Frame: baseline, one month, 6 months ]Health-related quality of life (as measured by the EQ-5D questionnaire)
- Functional outcome [ Time Frame: baseline, 1 month, 6 months ]Functional outcome following implant removal as assessed with the Lower Extremity Functional Scale (LEFS). The LEFS can be used by clinicians as a measure of patients' initial function, ongoing progress and outcome, as well as to set functional goals. The LEFS can be used to evaluate the functional impairment of a patient with a disorder of one or both lower extremities. It can be used to monitor the patient over time and to evaluate the effectiveness of an intervention
- Patient satisfaction [ Time Frame: 1 month, 6 months ]Patient satisfaction following implant removal as measured by a ten-point Visual Analog Scale
- Health care resources utilization [ Time Frame: baseline, 1 month, 6 months ]Health care resources utilization at baseline, 1 month and 6 months after implant removal (including amongst others, number of visits to the general practitioner and use of home care organizations) as measured by way of a combination of the Dutch iMTA Medical Consumption Questionnaire (iMCQ) and iMTA Productivity Cost Questionnaire (iPCQ) (adapted to the study setting).
- Costs [ Time Frame: Costs per quality adjusted life year ]Costs (economic evaluation including budget impact analysis): the economic evaluation of antibiotic prophylaxis in patients scheduled for implant removal (following a foot, ankle or lower leg fracture) against no prophylaxis as its best alternative will be performed as a cost-effectiveness (CEA) as well as a cost-utility (CUA) analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02225821
|Medisch Centrum Alkmaar|
|Academic Medical Center|
|Onze Lieve Vrouwe Gasthuis|
|Sint Lucas Andreas Ziekenhuis|
|VU Medisch Centrum|
|Rode Kruis Ziekenhuis|
|Reinier de Graaf|
|Den Haag, Netherlands|
|Study Chair:||Manouk Backes, MD, MSc||Academic Medical Center/Sint Lucas Andreas Hospital|
|Study Director:||Tim Schepers, MD, PhD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|