How to Prevent Post-surgery Infections (Bundle)
Evaluation of a Bundle of Actions to Prevent Skin Infections
Evaluation of the effectiveness in reducing the bacterial load on the skin of bedridden opatients through the use of two different cleaning and washing systems (swash bathing gloves vs pre-soaped sponges). The evaluation will be carried out on a daily basis and will begin on the first day after surgery for 3 consecutive days
Studieoversikt
Status
Detaljert beskrivelse
Since bed is recognized as a critical time for the onset of skin superinfections, the study aims to evaluate, by comparison, two different methods of managing bedridden patients using time spent for hygiene, daily skin pH measurement and samples for cilture tests
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Giorgio Oriani, Physician - Anesthetist
- Telefonnummer: +39335225452
- E-post: giorgio.oriani@grupposandonato.it
Studer Kontakt Backup
- Navn: Elena Cittera
Studiesteder
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Milan, Italia
- Rekruttering
- Istituto Clinico San Siro
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Age over 18 -
- Both sexes
- ASA III with need of monitoring
- Major surgery (Hip, Knee- Shoulder-first or revision)
Exclusion Criteria:
- Lack of consent
- Poor cooperation
- Post-operative delirium
- Pregnant women
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Swab washing group, that means we want to use a specific swab for cleaning
Evaluation of the effectiveness in reducing the bacterial load on the skin of bedridden patients . The evaluations will be carried out on a daily basis and will begin on the first day after surgery for 3 consecutive days. Evaluation is comprehensive of pH value before and after cleaning and cultural exam before and after |
The method will be the same of the swab arm. The goal is to compare the two groups looking at any differences
Andre navn:
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Sham-komparator: Pre-soaped sponges, using an usual methods for skin cleaning
Evaluation of the effectiveness in reducing the bacterial load on the skin of bedridden patients . The evaluations will be carried out on a daily basis and will begin on the first day after surgery for 3 consecutive days. Evaluation is comprehensive of pH value before and after cleaning and cultural exam before and after |
Procedure/Surgery: Sponge group: Use of this device for skin detersion, measuring also pH test and coltural examination before and after cleaning Description: we want to compare sponge detersion in bedridden patient, looking at pH test and coltural examination before and after surgery |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Evaluation of the effectiveness in reducing the bacterial load on the skin of bedridden patients through the use of two different cleaning and washing systems . Two different devices (swab vs sponge) will be compared.
Tidsramme: 18 months
|
Evaluation of pH before and after cleaning activity looking at the pH skin (using a dedicated device) and coltural charge befdore and after cleaning. These tests will be done three days after surgery, and the results will be collected in an Excel file to prepare a future analysis |
18 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Evaluation of time spent for cleaning and patient satisfaction using one device for three days. The device choice is depending on randomization file and the evaluator is blind of the device used
Tidsramme: three days for each patient of the two groups, plus a follow up 30 days afetr surgery
|
This evaluation will be carried out on a daily frequence and will begin on the first day after surgery and for three days |
three days for each patient of the two groups, plus a follow up 30 days afetr surgery
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Giorgio Oriani, IRCCS OGSA - Site Istituto San Siro
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Bundle to prevent infection
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
If someone will be interested in reproduce this study or proceed in this direction we surely would like to give our data
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- ICF
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
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