دورية أكاديمية
أعرض في EDS

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

التفاصيل البيبلوغرافية
العنوان: Wound Infections Following Implant removal below the knee: the effect of antibiotic prophylaxis; the WIFI-trial, a multi-centre randomized controlled trial.
المؤلفون: Backes M; 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., Dingemans SA; 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., Schep NW; 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., Bloemers FW; Traumasurgery, Department of Surgery, VU University Medical Center, P.O. Box 7057, 1007, MB, Amsterdam, The Netherlands. fw.bloemers@vumc.nl., Van Dijkman B; Department of Surgery, Flevo Hospital, P.O. Box 3005, 1300, EG, Almere, The Netherlands. bvdijkman@flevoziekenhuis.nl., Garssen FP; Department of Surgery, Hospital Amstelland, P.O. Box 328, 1180, AH, Amsterdam, The Netherlands. frgar@zha.nl., Haverlag R; Department of Surgery, Onze Lieve Vrouwe Hospital, P.O. Box 95500, 1090, HM, Amsterdam, The Netherlands. r.haverlag@olvg.nl., Hoogendoorn JM; Department of Surgery, MC Haaglanden, P.O. Box 432, 2501, CK, The Hague, The Netherlands. j.hoogendoorn@mchaaglanden.nl., Joosse P; Department of Surgery, Medical Center Alkmaar, P.O. Box 501, 1800, AM, Alkmaar, The Netherlands. p.joosse@mca.nl., Mirck B; Department of Surgery, Red Cross Hospital, P.O. Box 1074, 1940EB, Beverwijk, The Netherlands. bmirck@rkz.nl., Postma V; Department of Surgery, MC Zuiderzee, P.O. Box 5000, 8200, GA, Lelystad, The Netherlands. v.postma@mcgroep.com., Ritchie E; Department of Surgery, Rijnland Hospital, P.O. Box 4240, 2350, CC, Leiderdorp, The Netherlands. e.ritchie@rijnland.nl., Roerdink WH; Department of Surgery, Deventer Hospital, P.O. Box 5001, 7400, GC, Deventer, The Netherlands. roerdink@dz.nl., Sintenie JB; Department of Surgery, Elkerliek Hospital, P.O. Box 98, 5700, AB, Helmond, The Netherlands. sintenie@hotmail.com., Soesman NM; Department of Surgery, Vlietland Hospital, P.O. Box 215, 3100, AE, Schiedam, The Netherlands. nsoesman@vlietlandziekenhuis.nl., Sosef NL; Department of Surgery, Spaarne Hospital, P.O. Box 770, 2130, AT, Hoofddorp, The Netherlands. nsosef@spaarneziekenhuis.nl., Twigt BA; Department of Surgery, BovenIJ Hospital, PO Box 37610, 1030, BD, Amsterdam, The Netherlands. b.twigt@bovenij.nl., Van Veen RN; Department of Surgery, Sint Lucas Andreas Hospital, PO Box 9243, 1006, AE, Amsterdam, The Netherlands. r.vanveen@slaz.nl., Van der Veen AH; Department of Surgery, Catharina Hospital, P.O. Box 1350, 5602, ZA, Eindhoven, The Netherlands. alexander.vd.veen@catharinaziekenhuis.nl., Van Velde R; Department of Surgery, Tergooi Hospitals, P.O. Box 10016, 1201, DA, Hilversum, The Netherlands. rvanvelde@tergooi.nl., Vos DI; Department of Surgery, Amphia Hospital, P.O. Box 90157, 4800, RL, Breda, The Netherlands. DVos@amphia.nl., De Vries MR; Department of Surgery, Reinier de Graaf Hospital, P.O. Box 5011, 2600, GA, Delft, The Netherlands. M.deVries@rdgg.nl., Winkelhagen J; Department of Surgery, Westfries Hospital, P.O. Box 600, 1620, AR, Hoorn, The Netherlands. j.winkelhagen@westfriesgasthuis.nl., Goslings JC; 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., Schepers T; Trauma Unit, Department of Surgery, Academic Medical Center, University of Amsterdam, P.O. Box 22660, 1100, DD, Amsterdam, The Netherlands. t.schepers@amc.nl.
المصدر: BMC surgery [BMC Surg] 2015 Feb 06; Vol. 15, pp. 12. Date of Electronic Publication: 2015 Feb 06.
نوع المنشور: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 100968567 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2482 (Electronic) Linking ISSN: 14712482 NLM ISO Abbreviation: BMC Surg Subsets: MEDLINE
أسماء مطبوعة: Original Publication: London : BioMed Central, [2001-
مواضيع طبية MeSH: Antibiotic Prophylaxis* , Device Removal*, Anti-Bacterial Agents/*therapeutic use , Cefazolin/*therapeutic use , Fracture Fixation, Internal/*instrumentation , Preoperative Care/*methods , Surgical Wound Infection/*prevention & control, Adolescent ; Adult ; Aged ; Aged, 80 and over ; Clinical Protocols ; Double-Blind Method ; Drug Administration Schedule ; Female ; Follow-Up Studies ; Foot/surgery ; Humans ; Injections, Intravenous ; Leg/surgery ; Male ; Middle Aged ; Treatment Outcome ; Young Adult
مستخلص: 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).
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 Registration: 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.
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سلسلة جزيئية: NTR NTR4393
ClinicalTrials.gov NCT02225821
المشرفين على المادة: 0 (Anti-Bacterial Agents)
IHS69L0Y4T (Cefazolin)
تواريخ الأحداث: Date Created: 20150515 Date Completed: 20160720 Latest Revision: 20181202
رمز التحديث: 20231215
مُعرف محوري في PubMed: PMC4429659
DOI: 10.1186/1471-2482-15-12
PMID: 25972101
قاعدة البيانات: MEDLINE
الوصف
تدمد:1471-2482
DOI:10.1186/1471-2482-15-12