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| ID | Type | Description | Link |
|---|---|---|---|
| 112210 | Other Grant/Funding Number | La Fundació La Marató de TV3 |
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| Name | Class |
|---|---|
| Asociacion Colaboracion Cochrane Iberoamericana | OTHER |
| European Clinical Research Infrastructure Network | OTHER |
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The purpose of this trial is to make a comparison between the use of antiseptic silver alloy-coated silicone urinary catheters and the use of conventional silicone urinary catheters in spinal cord injured patients to prevent urinary infections.
Antiseptic Silver Alloy-Coated Silicone Urinary Catheters seems to be a promising intervention to reduce urinary tract infections; however, research evidence cannot be extrapolated to spinal cord injured patients.
The study is an open, randomized, multicentric, and parallel clinical trial with blinded assessment. The study includes spinal cord injured patients who require at least seven days of urethral catheterization as a method of bladder voiding. Participants are on-line centrally randomized and allocated to one of the two interventions (Antiseptic Urinary Catheters or Conventional Catheters). Catheters are used for a maximum period of 30 days or removed earlier at the clinician criteria.
The main outcome is the incidence of urinary tract infections 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.
The aim of this study is to assess whether silver alloy-coated silicone urinary catheters reduce urinary infections in spinal cord injured patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silver Alloy-Coated Urinary Catheters | Experimental | Bactiguard® Infection Protection coating consists of noble metals such as gold, palladium and silver. Trained health staff performs urethral catheterization and select the most adequate catheter size. To ensure aseptic conditions they are asked to strictly follow the current protocol in their respective centers. Indwelling urethral catheters are periodically replaced about 30 days of use; to not interfere with current clinical practice, the policy of each center (or the investigator criteria) for catheter replacement and removal is considered valid for this study. |
|
| Conventional Urinary Catheter | Other | Conventional or standard urinary catheters are those commonly used in each study center, most of them made of silicone or silicone-latex. Trained health staff performs urethral catheterization and select the most adequate catheter size. To ensure aseptic conditions they are asked to strictly follow the current protocol in their respective centers. Indwelling urethral catheters are periodically replaced about 30 days of use; to not interfere with current clinical practice, the policy of each center (or the investigator criteria) for catheter replacement and removal is considered valid for this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silver Alloy-Coated Urinary Catheters | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of catheter associated urinary tract infection | Is considered that a patient suffer a urinary tract infection if they have at least one suggestive sign or symptom with no other recognized cause and a positive urine culture with no more than 2 species of microorganisms. An urinary tract infection is considered catheter associated if the specimen collection is performed at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first). | at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first) |
| Measure | Description | Time Frame |
|---|---|---|
| Asymptomatic urinary tract infection | A positive urine culture with no more than 2 species of microorganisms(collected at any time from catheterization procedure and 30th day, catheter removal or catheter replacement, whichever occurs first), and no signs or symptoms. | at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first) |
| Measure | Description | Time Frame |
|---|---|---|
| Direct costs | Calculation of direct costs attributable to the use of intervention or control urinary catheters and their complications | From catheterization procedure and 30th day, catheter removal or catheter replacement or finalization of complication(s) or related treatment(s), whichever last longer. |
| Number of participants with adverse events related to catheterization as a Measure of Safety and Tolerability |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xavier Bonfill, MD, PhD | Asociacion Colaboracion Cochrane Iberoamericana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mutual de la Seguridad Chilena | Santiago | 4848 | Chile | |||
| Azienda Ospedaliero-Universitaria - Ospedali Riuniti di Ancona - Unità Spinale |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23895463 | Background | Bonfill X, Rigau D, Jauregui-Abrisqueta ML, Barrera Chacon JM, de la Barrera SS, Aleman-Sanchez CM, Bea-Munoz M, Moraleda Perez S, Borau Duran A, Espinosa Quiros JR, Ledesma Romano L, Fuertes ME, Araya I, Martinez-Zapata MJ. 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. BMC Urol. 2013 Jul 30;13:38. doi: 10.1186/1471-2490-13-38. |
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| Conventional Urinary Catheter | Device |
|
|
| Bacteremic urinary tract infection | Those with the primary outcome and with a positive blood culture with at least 1 matching uropathogen microorganism to the urine culture. | at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first) |
Any untoward medical occurrence related to urinary catheterization |
| at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first) |
| Ancona |
| Italy |
| Azienda Ospedaliero-Universitaria Policlinico di Bari- Unità Operativa di Medicina Fisica e Riabilitazione e Unità Spinale Unipolare | Bari | 70124 | Italy |
| Unità Operative Recupero e Riabilitazione Funzionale e Gravi Cerebrolesioni Acquisite | Ceglie Messapica | 72013 | Italy |
| Unità Spinale Unipolare | Rome | 00142 | Italy |
| Centro de Medicina de Reabilitação de Alcoitão | Alcoitão | Alcabideche | 2649-506 | Portugal |
| Centro Clínico Académico - Braga, Associação (2CA-Braga) | Braga | 4710-243 | Portugal |
| Centro Hospitalar do Porto | Porto | 4099-001 | Portugal |
| Complexo Hospitalario Universitario A Coruña | A Coruña | A Coruña | Spain |
| Hospital de Neurorrehabilitación Instituto Guttmann | Badalona | Barcelona | Spain |
| Hospital Universitario Puerta del Mar | Cadiz | Cadiz | Spain |
| Complejo Hospitalario Universitario Insular - Materno Infantil de Canarias | Las Palmas de Gran Canaria | Las Palmas | Spain |
| Hospital Universitario La Paz | Madrid | Madrid | Spain |
| Hospital Universitario Central de Asturias | Oviedo | Principality of Asturias | Spain |
| Hospital Universitario Virgen del Rocío | Seville | Sevilla | Spain |
| Hospital Nacional de Parapléjicos | Toledo | Toledo | Spain |
| Hospital Universitario Cruces | Barakaldo | Vizcaya | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | Zaragoza | Spain |
| Dokuz Eylul University Dept. of Physical Medicine and Rehabilitation | Alsancak | İzmir | 35210 | Turkey (Türkiye) |
| Ege University Dept. of Physical Medicine and Rehabilitation | Bornova | İzmir | 35040 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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