Wound Infections Following Implant Removal
WIFI
Antibiotic Prophylaxis to Prevent Wound Infections Following Implant Removal
2 other identifiers
interventional
500
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2014
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2014
CompletedFirst Posted
Study publicly available on registry
August 26, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedDecember 22, 2016
December 1, 2016
2 years
August 25, 2014
December 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative wound infection (POWI)
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.
30 days
Secondary Outcomes (4)
Health-related quality of life
baseline, one month, 6 months
Functional outcome
baseline, 1 month, 6 months
Patient satisfaction
1 month, 6 months
Health care resources utilization
baseline, 1 month, 6 months
Other Outcomes (1)
Costs
Costs per quality adjusted life year
Study Arms (2)
antibiotic prophylaxis
ACTIVE COMPARATORa single gift of 1000 mg cefazolin in 10 cc of NaCl 0.9% (intervention group)
No antibiotic prophylaxis
PLACEBO COMPARATORa single gift of 10 cc NaCl 0.9%, given in the same manner (control group).
Interventions
Eligibility Criteria
You may qualify if:
- Patients ≥18 years and ≤75 years of all ethnic backgrounds
- Implant removal following foot, ankle and/or lower leg surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Medisch Centrum Alkmaar
Alkmaar, Netherlands
Flevoziekenhuis
Almere Stad, 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
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
MC Haaglanden
The Hague, Netherlands
Related Publications (3)
Backes M, Schep NW, Luitse JS, Goslings JC, Schepers T. Indications for implant removal following intra-articular calcaneal fractures and subsequent complications. Foot Ankle Int. 2013 Nov;34(11):1521-5. doi: 10.1177/1071100713502466. Epub 2013 Sep 13.
PMID: 24038057BACKGROUNDBackes M, Dingemans SA, Schep NW, Bloemers FW, Van Dijkman B, Garssen FP, Haverlag R, Hoogendoorn JM, Joosse P, Mirck B, Postma V, Ritchie E, Roerdink WH, Sintenie JB, Soesman NM, Sosef NL, Twigt BA, Van Veen RN, Van der Veen AH, Van Velde R, Vos DI, De Vries MR, Winkelhagen J, Goslings JC, Schepers T. Wound Infections Following Implant removal below the knee: the effect of antibiotic prophylaxis; the WIFI-trial, a multi-centre randomized controlled trial. BMC Surg. 2015 Feb 6;15:12. doi: 10.1186/1471-2482-15-12.
PMID: 25972101BACKGROUNDBackes M, Dingemans SA, Dijkgraaf MGW, van den Berg HR, van Dijkman B, Hoogendoorn JM, Joosse P, Ritchie ED, Roerdink WH, Schots JPM, Sosef NL, Spijkerman IJB, Twigt BA, van der Veen AH, van Veen RN, Vermeulen J, Vos DI, Winkelhagen J, Goslings JC, Schepers T; WIFI Collaboration Group. Effect of Antibiotic Prophylaxis on Surgical Site Infections Following Removal of Orthopedic Implants Used for Treatment of Foot, Ankle, and Lower Leg Fractures: A Randomized Clinical Trial. JAMA. 2017 Dec 26;318(24):2438-2445. doi: 10.1001/jama.2017.19343.
PMID: 29279933DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
August 25, 2014
First Posted
August 26, 2014
Study Start
November 1, 2014
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
December 22, 2016
Record last verified: 2016-12