- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03976466
Profylakse af periprostetiske ledinfektioner med calciumsulfatperler hos patienter med ikke-modificerbare risikofaktorer. (Stimulan)
Anvendelse af antibiotikumfyldt calciumsulfat som profylakse til patienter med ikke-modificerbare risikofaktorer for periprostetiske ledinfektioner
At demonstrere den profylaktiske effekt af calciumsulfatperler fyldt med antibiotika hos patienter med ikke-modificerbare risikofaktorer, som vil gennemgå en hofte- eller knæledsudskiftning, sammenlignet med en kontrolgruppe.
At kende de økonomiske omkostninger, der genereres ved antibiotikaprofylakse med calciumsulfatperler hos patienter, der gennemgår hofte- eller knæledsudskiftning med ikke-modificerbare risikofaktorer.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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Tlalnepantla, Mexico, 54090
- HOSPITAL REGIONAL TLALNEPANTLA ISSEMyM
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inklusionskriterier:
- patienter med brud eller slidgigt i hofte eller knæ, der kræver behandling med ledudskiftning.
- patienter, der har nogen af de ikke-modificerbare risikofaktorer før operationen eller under den transoperative periode.
- Patienter med ret til ISSEMyM (Instituto de Seguridad Social del Estado de Mexico y Municipios)
Ekskluderingskriterier:
- Patienter, der mister deres gyldighed af institutionelle rettigheder og ikke følger op
- Patienter, der dør under undersøgelsen på grund af andre årsager, der ikke er relateret til den ortopædiske procedure.
- Patienter, der ikke har nogen af risikofaktorerne for periprostetisk infektion
- Patienter, der er allergiske over for vancomycin eller ceftriaxon.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Calciumsulfat gruppe
Gruppe af medlemmer, der vil blive underkastet profylakse med medicinske calciumsulfatperler til hofte- eller knæledsudskiftning
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Antibiotisk profylakse hos patienter med ikke-modificerbare risikofaktorer for periprostetisk ledinfektion
Andre navne:
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Aktiv komparator: Kontrolgruppe
Gruppe af medlemmer, der vil blive underkastet klassisk profylakse for hofte- eller knæledsudskiftning
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Antibiotisk profylakse hos patienter med ikke-modificerbare risikofaktorer for periprostetisk ledinfektion
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Deltagere, der opnår en infektionsrate for periprostetiske led i nedre hofte eller knæ med lokal versus konventionel intravenøs antibiotikaprofilakser, målt med CRP, ERS i serum- og sinovialvæskeleukocytter, i løbet af den 12-ugers observationsperiode.
Tidsramme: Dag 5, uge 4, 8 og 12
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Akut periprostetisk knæ- eller hofteinfektion blev bestemt ved hjælp af CRP- og ESR-serumbiomarkører, som er de mest almindeligt publicerede serumbiomarkører i litteraturen om periprostetiske ledinfektioner.
Afskæringspunktet for CRP blev betragtet som 93 mg/l og 44 mm/time for ESR.
Serumbiomarkørprøven blev taget og evalueret på dag 5 og uge 4, 8 og 12. Leukocytter i ledvæske er blandt kriterierne for definition af periprostetisk ledinfektion med et afskæringspunkt over 12.800 celler/µL og blev kun inkluderet, hvis serumbiomarkører var forhøjede.
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Dag 5, uge 4, 8 og 12
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Opholdslængde som en indikator for hospitalets økonomiske byrde
Tidsramme: Kirurgisk procedure dag til hospitalsudskrivning.
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Opholdets længde er en vigtig indikator for effektivitet og hospitalsøkonomiske byrde.
Reduktionen i antallet af indlæggelsesdage resulterer i lavere risiko for infektion og færre medicinbivirkninger og reduceret behov for hospitalsforsyninger.
Forskellen i de gennemsnitlige indlæggelsesdage mellem begge grupper repræsenterer indirekte de økonomiske omkostninger, som hospitalet bruger.
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Kirurgisk procedure dag til hospitalsudskrivning.
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
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- Meza-Lopez LR, Cigarroa-Lopez JA, Hernandez-Meneses S, Castan-Flores DA, Mendoza-Zavala GH, Barragan-Zamora JA, Carrillo-Munoz A, Munguia-Canales DA. [Dissolvable and extended release antibiotic beads in mediastinoscopic management of mediastinitis after heart transplantation]. Arch Cardiol Mex. 2017 Apr-Jun;87(2):182-186. doi: 10.1016/j.acmx.2017.01.006. Epub 2017 Mar 2. No abstract available. Spanish.
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- Howlin RP, Brayford MJ, Webb JS, Cooper JJ, Aiken SS, Stoodley P. Antibiotic-loaded synthetic calcium sulfate beads for prevention of bacterial colonization and biofilm formation in periprosthetic infections. Antimicrob Agents Chemother. 2015 Jan;59(1):111-20. doi: 10.1128/AAC.03676-14. Epub 2014 Oct 13.
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- Kallala R, Harris WE, Ibrahim M, Dipane M, McPherson E. Use of Stimulan absorbable calcium sulphate beads in revision lower limb arthroplasty: Safety profile and complication rates. Bone Joint Res. 2018 Nov 3;7(10):570-579. doi: 10.1302/2046-3758.710.BJR-2017-0319.R1. eCollection 2018 Oct.
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- de Lachica JCV, Reyes SSS, Urena JAP, Fragoso MAR. Decrease in acute periprosthetic joint infections incidence with vancomycin-loaded calcium sulfate beads in patients with non-modifiable risk factors. A randomized clinical trial. J ISAKOS. 2022 Dec;7(6):201-205. doi: 10.1016/j.jisako.2022.08.002. Epub 2022 Aug 13.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
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