Evidence map›Paper›PMID 25972101›Full record

Trial reportBMC surgery2015

Wound Infections Following Implant removal below the knee: the effect of antibiotic prophylaxis; the WIFI-trial, a multi-centre randomized controlled trial.

Manouk Backes, Siem A Dingemans, Niels W L Schep, Frank W Bloemers, Bart Van Dijkman, Frank P Garssen, Robert Haverlag, Jochem M Hoogendoorn, Pieter Joosse, Boj Mirck and 15 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC surgery, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02225821 (Antibiotic Prophylaxis to Prevent Wound Infections Following Implant Removal), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.6field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02225821 phase4completednot on this map

Antibiotic Prophylaxis to Prevent Wound Infections Following Implant Removal

TypeinterventionalSponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Ran2014 to 2016Enrolled500ConditionsSurgical Wound InfectionArmsCephalozin, Sodium chloride
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors at 20 institutions in 1 country.

Manouk BackesTrauma Unit, Department of Surgery, Academic Medical Center, University of Amsterdam, P.O. Box 22660, 1100, DD, Amsterdam, The Netherlands. m.backes@amc.nl.
Siem A DingemansTrauma Unit, Department of Surgery, Academic Medical Center, University of Amsterdam, P.O. Box 22660, 1100, DD, Amsterdam, The Netherlands. s.a.dingemans@amc.nl.
Niels W L SchepTrauma Unit, Department of Surgery, Academic Medical Center, University of Amsterdam, P.O. Box 22660, 1100, DD, Amsterdam, The Netherlands. n.w.schep@amc.nl.
Frank W BloemersTraumasurgery, Department of Surgery, VU University Medical Center, P.O. Box 7057, 1007, MB, Amsterdam, The Netherlands. fw.bloemers@vumc.nl.
Bart Van DijkmanDepartment of Surgery, Flevo Hospital, P.O. Box 3005, 1300, EG, Almere, The Netherlands. bvdijkman@flevoziekenhuis.nl.
Frank P GarssenDepartment of Surgery, Hospital Amstelland, P.O. Box 328, 1180, AH, Amsterdam, The Netherlands. frgar@zha.nl.
Robert HaverlagDepartment of Surgery, Onze Lieve Vrouwe Hospital, P.O. Box 95500, 1090, HM, Amsterdam, The Netherlands. r.haverlag@olvg.nl.
Jochem M HoogendoornDepartment of Surgery, MC Haaglanden, P.O. Box 432, 2501, CK, The Hague, The Netherlands. j.hoogendoorn@mchaaglanden.nl.
Pieter JoosseDepartment of Surgery, Medical Center Alkmaar, P.O. Box 501, 1800, AM, Alkmaar, The Netherlands. p.joosse@mca.nl.
Boj MirckDepartment of Surgery, Red Cross Hospital, P.O. Box 1074, 1940EB, Beverwijk, The Netherlands. bmirck@rkz.nl.
Victor PostmaDepartment of Surgery, MC Zuiderzee, P.O. Box 5000, 8200, GA, Lelystad, The Netherlands. v.postma@mcgroep.com.
Ewan RitchieDepartment of Surgery, Rijnland Hospital, P.O. Box 4240, 2350, CC, Leiderdorp, The Netherlands. e.ritchie@rijnland.nl.
W Herbert RoerdinkDepartment of Surgery, Deventer Hospital, P.O. Box 5001, 7400, GC, Deventer, The Netherlands. roerdink@dz.nl.
Jan Bernard SintenieDepartment of Surgery, Elkerliek Hospital, P.O. Box 98, 5700, AB, Helmond, The Netherlands. sintenie@hotmail.com.
Nicolaj M R SoesmanDepartment of Surgery, Vlietland Hospital, P.O. Box 215, 3100, AE, Schiedam, The Netherlands. nsoesman@vlietlandziekenhuis.nl.
Nico L SosefDepartment of Surgery, Spaarne Hospital, P.O. Box 770, 2130, AT, Hoofddorp, The Netherlands. nsosef@spaarneziekenhuis.nl.
Bas A TwigtDepartment of Surgery, BovenIJ Hospital, PO Box 37610, 1030, BD, Amsterdam, The Netherlands. b.twigt@bovenij.nl.
Ruben N Van VeenDepartment of Surgery, Sint Lucas Andreas Hospital, PO Box 9243, 1006, AE, Amsterdam, The Netherlands. r.vanveen@slaz.nl.
Alexander H Van der VeenDepartment of Surgery, Catharina Hospital, P.O. Box 1350, 5602, ZA, Eindhoven, The Netherlands. alexander.vd.veen@catharinaziekenhuis.nl.
Romuald Van VeldeDepartment of Surgery, Tergooi Hospitals, P.O. Box 10016, 1201, DA, Hilversum, The Netherlands. rvanvelde@tergooi.nl.
Dagmar I VosDepartment of Surgery, Amphia Hospital, P.O. Box 90157, 4800, RL, Breda, The Netherlands. DVos@amphia.nl.
Mark R De VriesDepartment of Surgery, Reinier de Graaf Hospital, P.O. Box 5011, 2600, GA, Delft, The Netherlands. M.deVries@rdgg.nl.
Jasper WinkelhagenDepartment of Surgery, Westfries Hospital, P.O. Box 600, 1620, AR, Hoorn, The Netherlands. j.winkelhagen@westfriesgasthuis.nl.
J Carel GoslingsTrauma Unit, Department of Surgery, Academic Medical Center, University of Amsterdam, P.O. Box 22660, 1100, DD, Amsterdam, The Netherlands. j.c.goslings@amc.nl.
Tim SchepersTrauma Unit, Department of Surgery, Academic Medical Center, University of Amsterdam, P.O. Box 22660, 1100, DD, Amsterdam, The Netherlands. t.schepers@amc.nl.
University of Amsterdam · NLAcademic Medical Center · NLAmphia Ziekenhuis · NLAmsterdam UMC Location VUmc · NLDe Kinderkliniek · NLDeventer Ziekenhuis · NLElkerliek Ziekenhuis · NLFranciscus Vlietland · NLGGD Haaglanden · NLMedisch Centrum Alkmaar · NLOLVG · NLRadboud University Nijmegen · NLReinier de Graaf Hospital · NLRijnland Ziekenhuis · NLRijnstate Hospital · NLSint Lucas Andreas Hospital · NLSpaarne Ziekenhuis · NLTergooi · NLWestfriesgasthuis · NLZiekenhuis Amstelland · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn 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.

methodsThis 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). DISCUSSION: 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.

trial registrationThis 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.

Indexed as

Antibiotic ProphylaxisDevice RemovalAdolescentAdultAgedAged, 80 and overAnti-Bacterial AgentsCefazolinClinical ProtocolsDouble-Blind MethodDrug Administration ScheduleFemaleFollow-Up StudiesFootFracture Fixation, InternalHumansAnti-Bacterial AgentsCefazolin

Identifiers

PMID25972101
PMCPMC4429659
OpenAlexW2127752081

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.