A randomized controlled trial to assess the efficacy and cost-effectiveness of urinary catheters with silver alloy coating in spinal cord injured patients: trial protocol
Por:
Bonfill, X, Rigau, D, Jauregui-Abrisqueta, ML, Chacon, JMB, de la Barrera, SS, Aleman-Sanchez, CM, Bea-Munoz, M, Perez, SM, Duran, AB, Quiros, JRE, Romano, LL, Fuertes, ME, Araya, I, Martinez-Zapata, MJ
Publicada:
30 jul 2013
Resumen:
Background: Patients with non-acute spinal cord injury that carry indwelling urinary catheters have an increased risk of urinary tract infection (UTIs). Antiseptic Silver Alloy-Coated Silicone Urinary Catheters seems to be a promising intervention to reduce UTIs; however, actual evidence cannot be extrapolated to spinal cord injured patients. The aim of this trial is to make a comparison between the use of antiseptic silver alloy-coated silicone urinary catheters and the use of standard urinary catheters in spinal cord injured patients to prevent UTIs.
Methods/Design: The study will consist in an open, randomized, multicentre, and parallel clinical trial with blinded assessment. The study will include 742 spinal cord injured patients who require at least seven days of urethral catheterization as a method of bladder voiding. Participants will be online centrally randomized and allocated to one of the two study arms (silver alloy-coated or standard catheters). Catheters will be used for a maximum period of 30 days or removed earlier if the clinician considers it necessary. The main outcome will be the incidence of UTIs by the time of catheter removal or at day 30 after catheterization, the event that occurs first. Intention-to-treat analysis will be performed, as well as a primary analysis of all patients.
Discussion: The aim of this study is to assess whether silver alloy-coated silicone urinary catheters improve ITUs in spinal cord injured patients. ESCALE is intended to be the first study to evaluate the efficacy of the silver alloy-coated catheters in spinal cord injured patients.
Filiaciones:
Bonfill, X:
Hosp Santa Creu & Sant Pau, Serv Clin Epidemiol, Barcelona, Spain
Iberoamer Cochrane Ctr, Barcelona 08025, Spain
IIB St Pau, Inst Biomed Res, Barcelona 08025, Spain
CIBERESP, Barcelona, Spain
Univ Autonoma Barcelona, Dept Paediat Obstet & Gynaecol & Prevent Med, Bellaterra, Spain
Rigau, D:
Iberoamer Cochrane Ctr, Barcelona 08025, Spain
IIB St Pau, Inst Biomed Res, Barcelona 08025, Spain
Jauregui-Abrisqueta, ML:
Hosp Univ Cruces, Barakaldo Bizkaia 48903, Spain
Chacon, JMB:
Hosp Univ Virgen del Rocio, Seville 41013, Spain
de la Barrera, SS:
Complexo Hosp Univ A Coruna, La Coruna 15006, Spain
Aleman-Sanchez, CM:
Complejo Hosp Univ Insular Materno Infantil, Las Palmas Gran Canaria 35016, Spain
Bea-Munoz, M:
Hosp Univ Cent Asturias, Oviedo 33006, Spain
Perez, SM:
Hosp Univ La Paz, Madrid 28046, Spain
Duran, AB:
Hosp Neurorrehabil, Inst Guttmann, Badalona 08916, Spain
Quiros, JRE:
Hosp Univ Puerta del Mar, Cadiz 11500, Spain
Romano, LL:
Hosp Univ Miguel Servet, Zaragoza 50009, Spain
Fuertes, ME:
Hosp Nacl Paraplejicos Toledo, Toledo 45071, Spain
Araya, I:
Univ Chile, Fac Odontol, Dept Cirugia & Traumatol Maxilofacial, Santiago 8380492, Chile
Martinez-Zapata, MJ:
Iberoamer Cochrane Ctr, Barcelona 08025, Spain
IIB St Pau, Inst Biomed Res, Barcelona 08025, Spain
CIBERESP, Barcelona, Spain
Gold
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