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
Studieöversikt
Status
Detaljerad beskrivning
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
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Giorgio Oriani, Physician - Anesthetist
- Telefonnummer: +39335225452
- E-post: giorgio.oriani@grupposandonato.it
Studera Kontakt Backup
- Namn: Elena Cittera
Studieorter
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Milan, Italien
- Rekrytering
- Istituto Clinico San Siro
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / 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
Andra namn:
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Sham Comparator: 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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.
Tidsram: 18 months
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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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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
Tidsram: three days for each patient of the two groups, plus a follow up 30 days afetr surgery
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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
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Giorgio Oriani, IRCCS OGSA - Site Istituto San Siro
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Bundle to prevent infection
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
If someone will be interested in reproduce this study or proceed in this direction we surely would like to give our data
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- ICF
- CSR
Läkemedels- och apparatinformation, studiedokument
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