期刊论文详细信息
BMC Surgery
Wound Infections Following Implant removal below the knee: the effect of antibiotic prophylaxis; the WIFI-trial, a multi-centre randomized controlled trial
Study Protocol
Dagmar I Vos1  Bas A Twigt2  Alexander H Van der Veen3  W Herbert Roerdink4  Jan Bernard Sintenie5  Bart Van Dijkman6  Frank P Garssen7  Jochem M Hoogendoorn8  Victor Postma9  Pieter Joosse1,10  Robert Haverlag1,11  Boj Mirck1,12  Mark R De Vries1,13  Ewan Ritchie1,14  Ruben N Van Veen1,15  Nico L Sosef1,16  Romuald Van Velde1,17  Nicolaj MR Soesman1,18  Jasper Winkelhagen1,19  J Carel Goslings2,20  Siem A Dingemans2,20  Tim Schepers2,20  Niels WL Schep2,20  Manouk Backes2,21  Frank W Bloemers2,22 
[1] Department of Surgery, Amphia Hospital, P.O. Box 90157, 4800, Breda, RL, The Netherlands;Department of Surgery, BovenIJ Hospital, PO Box 37610, 1030, Amsterdam, BD, The Netherlands;Department of Surgery, Catharina Hospital, P.O. Box 1350, 5602, Eindhoven, ZA, The Netherlands;Department of Surgery, Deventer Hospital, P.O. Box 5001, 7400, Deventer, GC, The Netherlands;Department of Surgery, Elkerliek Hospital, P.O. Box 98, 5700, Helmond, AB, The Netherlands;Department of Surgery, Flevo Hospital, P.O. Box 3005, 1300, Almere, EG, The Netherlands;Department of Surgery, Hospital Amstelland, P.O. Box 328, 1180, Amsterdam, AH, The Netherlands;Department of Surgery, MC Haaglanden, P.O. Box 432, 2501, The Hague, CK, The Netherlands;Department of Surgery, MC Zuiderzee, P.O. Box 5000, 8200, Lelystad, GA, The Netherlands;Department of Surgery, Medical Center Alkmaar, P.O. Box 501, 1800, Alkmaar, AM, The Netherlands;Department of Surgery, Onze Lieve Vrouwe Hospital, P.O. Box 95500, 1090, Amsterdam, HM, The Netherlands;Department of Surgery, Red Cross Hospital, P.O. Box 1074, 1940EB, Beverwijk, The Netherlands;Department of Surgery, Reinier de Graaf Hospital, P.O. Box 5011, 2600, Delft, GA, The Netherlands;Department of Surgery, Rijnland Hospital, P.O. Box 4240, 2350, Leiderdorp, CC, The Netherlands;Department of Surgery, Sint Lucas Andreas Hospital, PO Box 9243, 1006, Amsterdam, AE, The Netherlands;Department of Surgery, Spaarne Hospital, P.O. Box 770, 2130, Hoofddorp, AT, The Netherlands;Department of Surgery, Tergooi Hospitals, P.O. Box 10016, 1201, Hilversum, DA, The Netherlands;Department of Surgery, Vlietland Hospital, P.O. Box 215, 3100, Schiedam, AE, The Netherlands;Department of Surgery, Westfries Hospital, P.O. Box 600, 1620, Hoorn, AR, The Netherlands;Trauma Unit, Department of Surgery, Academic Medical Center, University of Amsterdam, P.O. Box 22660, 1100, Amsterdam, DD, The Netherlands;Trauma Unit, Department of Surgery, Academic Medical Center, University of Amsterdam, P.O. Box 22660, 1100, Amsterdam, DD, The Netherlands;Department of Surgery, Sint Lucas Andreas Hospital, PO Box 9243, 1006, Amsterdam, AE, The Netherlands;Traumasurgery, Department of Surgery, VU University Medical Center, P.O. Box 7057, 1007, Amsterdam, MB, The Netherlands;
关键词: Antibiotic prophylaxis;    Postoperative wound infection;    Implant removal;    Fracture surgery;    Functional outcome;   
DOI  :  10.1186/1471-2482-15-12
 received in 2014-11-19, accepted in 2015-01-09,  发布年份 2015
来源: Springer
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【 摘 要 】

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).DiscussionIf 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.

【 授权许可】

CC BY   
© Backes et al.; licensee BioMed Central. 2015

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