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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
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
AO Research Fund
Information provided by (Responsible Party):
J.C. Goslings, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary:

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

Detailed Description:
See study protocol

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: antibiotic prophylaxis
a single gift of 1000 mg cefazolin in 10 cc of NaCl 0.9% (intervention group)
Drug: Cephalozin
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%




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Health-related quality of life [ Time Frame: baseline, one month, 6 months ]
    Health-related quality of life (as measured by the EQ-5D questionnaire)

  2. 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

  3. Patient satisfaction [ Time Frame: 1 month, 6 months ]
    Patient satisfaction following implant removal as measured by a ten-point Visual Analog Scale

  4. 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).


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Netherlands
Medisch Centrum Alkmaar
Alkmaar, Netherlands
Flevoziekenhuis
Almere, Netherlands
Amstelland Ziekenhuis
Amstelveen, Netherlands
Academic Medical Center
Amsterdam, Netherlands
BovenIJ Ziekenhuis
Amsterdam, Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands
Sint Lucas Andreas Ziekenhuis
Amsterdam, Netherlands
VU Medisch Centrum
Amsterdam, Netherlands
Gelre Ziekenhuizen
Apeldoorn, Netherlands
Rode Kruis Ziekenhuis
Beverwijk, Netherlands
Amphia Ziekenhuis
Breda, Netherlands
Reinier de Graaf
Delft, Netherlands
MC Haaglanden
Den Haag, Netherlands
Deventer Ziekenhuis
Deventer, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Elkerliek Ziekenhuis
Helmond, Netherlands
Tergooiziekenhuizen
Hilversum, Netherlands
Spaarne Ziekenhuis
Hoofddorp, Netherlands
Westfries Gasthuis
Hoorn, Netherlands
Rijnland Ziekenhuis
Leiderdorp, Netherlands
Vlietland Ziekenhuis
Schiedam, Netherlands
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ZonMw: The Netherlands Organisation for Health Research and Development
AO Research Fund
Investigators
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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)

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: J.C. Goslings, Prof. Dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02225821     History of Changes
Other Study ID Numbers: SB155014
NTR 4393 ( Other Identifier: Nederlands Trial Register )
First Posted: August 26, 2014    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by J.C. Goslings, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Implant Removal
Antibiotic Prophylaxis
Postoperative wound infection
Orthopedics
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Infection
Communicable Diseases
Wound Infection
Surgical Wound Infection
Surgical Wound
Wounds and Injuries
Postoperative Complications
Pathologic Processes