title: Wound Infections Following Implant removal below the knee: the effect of antibiotic prophylaxis; the WIFI-trial, a multi-centre randomized controlled trial.
abstract: BACKGROUND
  In the Netherlands about 18,000 procedures with implant removal are performed annually following open or closed reduction and fixation of fractures, of which 30-80% concern the foot, ankle and lower leg region. For clean surgical procedures, the rate of postoperative wound infections (POWI) should be less than ~2%. However, rates of 10-12% following implant removal have been reported, specifically after foot, ankle and lower leg fractures. Currently, surgeons individually decide if antibiotics prophylaxis is given, since no guideline exists. This leads to undesirable practice variation. The aim of the study is to assess the (cost-)effectiveness of a single intravenous gift of Cefazolin prior to implant removal following surgical fixation of foot, ankle and/or lower leg fractures.
  
  
  METHODS
  This is a double-blind randomized controlled trial in patients scheduled for implant removal following a foot, ankle or lower leg fracture. Primary outcome is a POWI within 30 days after implant removal. Secondary outcomes are quality of life, functional outcome and costs at 30 days and 6 months after implant removal. With 2 x 250 patients a decrease in POWI rate from 10% to 3.3% (expected rate in clean-contaminated elective orthopaedic trauma procedures) can be detected (Power = 80%, 2-sided alpha = 5%, including 15% lost to follow up).
  
  
  CONCLUSIONS
  If administration of prophylactic antibiotics prior to implant removal reduces the infectious complication rate, this will offer a strong argument to adopt this as standard practice of care. This will consequently lead to less physical and social disabilities and health care use. A preliminary, conservative estimation suggests yearly cost savings in the Netherlands of € 3.5 million per year.
  
  
  BACKGROUND
  This study is registered at Clinicaltrials.gov ( NCT02225821 ) and the Netherlands Trial Register ( NTR4393 ) and was granted permission by the Medical Ethical Review Committee of the Academic Medical Centre on October 7 2014.
authors.affiliation: Trauma Unit, Department of Surgery, Academic Medical Center, University of Amsterdam, P.O. Box 22660, 1100, DD, Amsterdam, The Netherlands. m.backes@amc.nl.|Department of Surgery, Sint Lucas Andreas Hospital, PO Box 9243, 1006, AE, Amsterdam, The Netherlands. m.backes@amc.nl.
authors.forename: Manouk
authors.initials: M
authors.lastname: Backes
authors.affiliation: Trauma Unit, Department of Surgery, Academic Medical Center, University of Amsterdam, P.O. Box 22660, 1100, DD, Amsterdam, The Netherlands. s.a.dingemans@amc.nl.
authors.forename: Siem A
authors.initials: SA
authors.lastname: Dingemans
authors.affiliation: Trauma Unit, Department of Surgery, Academic Medical Center, University of Amsterdam, P.O. Box 22660, 1100, DD, Amsterdam, The Netherlands. n.w.schep@amc.nl.
authors.forename: Niels W L
authors.initials: NW
authors.lastname: Schep
authors.affiliation: Traumasurgery, Department of Surgery, VU University Medical Center, P.O. Box 7057, 1007, MB, Amsterdam, The Netherlands. fw.bloemers@vumc.nl.
authors.forename: Frank W
authors.initials: FW
authors.lastname: Bloemers
authors.affiliation: Department of Surgery, Flevo Hospital, P.O. Box 3005, 1300, EG, Almere, The Netherlands. bvdijkman@flevoziekenhuis.nl.
authors.forename: Bart
authors.initials: B
authors.lastname: Van Dijkman
authors.affiliation: Department of Surgery, Hospital Amstelland, P.O. Box 328, 1180, AH, Amsterdam, The Netherlands. frgar@zha.nl.
authors.forename: Frank P
authors.initials: FP
authors.lastname: Garssen
authors.affiliation: Department of Surgery, Onze Lieve Vrouwe Hospital, P.O. Box 95500, 1090, HM, Amsterdam, The Netherlands. r.haverlag@olvg.nl.
authors.forename: Robert
authors.initials: R
authors.lastname: Haverlag
authors.affiliation: Department of Surgery, MC Haaglanden, P.O. Box 432, 2501, CK, The Hague, The Netherlands. j.hoogendoorn@mchaaglanden.nl.
authors.forename: Jochem M
authors.initials: JM
authors.lastname: Hoogendoorn
authors.affiliation: Department of Surgery, Medical Center Alkmaar, P.O. Box 501, 1800, AM, Alkmaar, The Netherlands. p.joosse@mca.nl.
authors.forename: Pieter
authors.initials: P
authors.lastname: Joosse
authors.affiliation: Department of Surgery, Red Cross Hospital, P.O. Box 1074, 1940EB, Beverwijk, The Netherlands. bmirck@rkz.nl.
authors.forename: Boj
authors.initials: B
authors.lastname: Mirck
authors.affiliation: Department of Surgery, MC Zuiderzee, P.O. Box 5000, 8200, GA, Lelystad, The Netherlands. v.postma@mcgroep.com.
authors.forename: Victor
authors.initials: V
authors.lastname: Postma
authors.affiliation: Department of Surgery, Rijnland Hospital, P.O. Box 4240, 2350, CC, Leiderdorp, The Netherlands. e.ritchie@rijnland.nl.
authors.forename: Ewan
authors.initials: E
authors.lastname: Ritchie
authors.affiliation: Department of Surgery, Deventer Hospital, P.O. Box 5001, 7400, GC, Deventer, The Netherlands. roerdink@dz.nl.
authors.forename: W Herbert
authors.initials: WH
authors.lastname: Roerdink
authors.affiliation: Department of Surgery, Elkerliek Hospital, P.O. Box 98, 5700, AB, Helmond, The Netherlands. sintenie@hotmail.com.
authors.forename: Jan Bernard
authors.initials: JB
authors.lastname: Sintenie
authors.affiliation: Department of Surgery, Vlietland Hospital, P.O. Box 215, 3100, AE, Schiedam, The Netherlands. nsoesman@vlietlandziekenhuis.nl.
authors.forename: Nicolaj M R
authors.initials: NM
authors.lastname: Soesman
authors.affiliation: Department of Surgery, Spaarne Hospital, P.O. Box 770, 2130, AT, Hoofddorp, The Netherlands. nsosef@spaarneziekenhuis.nl.
authors.forename: Nico L
authors.initials: NL
authors.lastname: Sosef
authors.affiliation: Department of Surgery, BovenIJ Hospital, PO Box 37610, 1030, BD, Amsterdam, The Netherlands. b.twigt@bovenij.nl.
authors.forename: Bas A
authors.initials: BA
authors.lastname: Twigt
authors.affiliation: Department of Surgery, Sint Lucas Andreas Hospital, PO Box 9243, 1006, AE, Amsterdam, The Netherlands. r.vanveen@slaz.nl.
authors.forename: Ruben N
authors.initials: RN
authors.lastname: Van Veen
authors.affiliation: Department of Surgery, Catharina Hospital, P.O. Box 1350, 5602, ZA, Eindhoven, The Netherlands. alexander.vd.veen@catharinaziekenhuis.nl.
authors.forename: Alexander H
authors.initials: AH
authors.lastname: Van der Veen
authors.affiliation: Department of Surgery, Tergooi Hospitals, P.O. Box 10016, 1201, DA, Hilversum, The Netherlands. rvanvelde@tergooi.nl.
authors.forename: Romuald
authors.initials: R
authors.lastname: Van Velde
authors.affiliation: Department of Surgery, Amphia Hospital, P.O. Box 90157, 4800, RL, Breda, The Netherlands. DVos@amphia.nl.
authors.forename: Dagmar I
authors.initials: DI
authors.lastname: Vos
authors.affiliation: Department of Surgery, Reinier de Graaf Hospital, P.O. Box 5011, 2600, GA, Delft, The Netherlands. M.deVries@rdgg.nl.
authors.forename: Mark R
authors.initials: MR
authors.lastname: De Vries
authors.affiliation: Department of Surgery, Westfries Hospital, P.O. Box 600, 1620, AR, Hoorn, The Netherlands. j.winkelhagen@westfriesgasthuis.nl.
authors.forename: Jasper
authors.initials: J
authors.lastname: Winkelhagen
authors.affiliation: Trauma Unit, Department of Surgery, Academic Medical Center, University of Amsterdam, P.O. Box 22660, 1100, DD, Amsterdam, The Netherlands. j.c.goslings@amc.nl.
authors.forename: J Carel
authors.initials: JC
authors.lastname: Goslings
authors.affiliation: Trauma Unit, Department of Surgery, Academic Medical Center, University of Amsterdam, P.O. Box 22660, 1100, DD, Amsterdam, The Netherlands. t.schepers@amc.nl.
authors.forename: Tim
authors.initials: T
authors.lastname: Schepers
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D019072:Antibiotic Prophylaxis; D002437:Cefazolin / Q000627:therapeutic use*; D002985:Clinical Protocols; D020878:Device Removal; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005528:Foot / Q000601:surgery; D005593:Fracture Fixation, Internal / Q000295:instrumentation*; D006801:Humans; D007275:Injections, Intravenous; D007866:Leg / Q000601:surgery; D008297:Male; D008875:Middle Aged; D011300:Preoperative Care / Q000379:methods*; D013530:Surgical Wound Infection / Q000517:prevention & control*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D002437:Cefazolin