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Recolonisation of Bacteria in Hands and Possible Bacterial Leakage From Glove Cuff in Cardiac Surgery
3 april 2017 bijgewerkt door: Camilla Wistrand, Örebro University, Sweden
Recolonisation of Bacteria in Hands and Possible Bacterial Leakage From Glove Cuff in Cardiac Surgery. Differences in Microbial Flora and Recolonisation Between Hospital and Non-hospital Persons. A Controlled Clinical Trial.
This study aims to investigate if recolonisation of the hand flora occur after surgical hand washing and is there a bacterial leakage at the glove cuff site in cardiac surgery?
Also investigate if thera are differences in microbial flora and recolonisation between hospital and non-hospital persons.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
With emerging antibiotic resistant bacteria it is necessary to try to prevent surgical site infections (SSIs).Not only because of suffering and death but also because of increased costs.
For a deep sternal infection the cost can be doubled or even tripled.
Sternal wound complications can occur from low numbers up to almost 10%, with different severity, depending on follow up routines In an intraoperative environment causative bacteria often originate from either patient or surgical team.
One of many preventing measures is to keep patients and surgical members as sterile as possible when it´s the number of bacteria that overcome the host defense that lead to infection.
The most common bacteria causing sternal infection is Coagulase negative staphylococci (CoNS) 46% Staphylococcus aureus, 26% and gram- negative bacteria, 18%.
One preventing measure is to wear surgical gloves, and to wear double gloving for easy detection of puncture in outer glove.
When using indicator gloves there becomes a dark spot were the hole is which tells you to change the glove.
At the glove cuff end it often indicate fluid of some sort by getting dark where the sleeve of the gown meets the glove cuff.
One may suspect that the fluid thrives from the hand, and if so does the fluid contains any bacteria from the hands.
In open heart surgery surgical team wear their gloves for a long period of time.
Research implicates that it occurs some recolonisation of bacteria inside the gloves.
Does recolonisation of the hand flora occur after surgical hand washing and is there a bacterial leakage at the glove cuff site?
It´s discussed that people that are in contact with hospitals carries more bacteria than others and being admitted to hospital before surgery is a risk factor.
It is also known that hospital workers are carriers of more bacteria and possibly also carriers of resistant bacteria.
At the other hand hospital workers often wash and disinfect their hands.
Are there differences in bacterial recolonization of hand flora between hospital staff at an operating department than people in average society who have little or no contact with hospitals?
Studietype
Ingrijpend
Inschrijving (Werkelijk)
28
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Örebro, Zweden, 701 85
- Örbro university hospital
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Operating nurse at the department and non-hospital persons
Exclusion Criteria:
- Participated previously in present study
- Use of gloves with antimicrobial effect
- Patient with a known infection
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Screening
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: OR nurse group
OR nurses (14) who agreed to participate were asked to perform a surgical hand disinfection accordingly to clinic routine.
When hands were dry cultures were first obtained at 3 sites, using a moist with saline nylon flocked swab (Copan ESwab, Italia SpA).
After hand disinfection; 1) in right hand palm, 2) between index finger and middle finger, 3) nail/cuticle of index finger.
When surgery were completed and before disposal of gloves and gown the fourth culture were taken where the glove cuff meets the gown sleeve, under and above, the inner glove of all OR nurses.When gloves were removed cultures were taken again at three sites on the hand, approximately 2-3 hours.
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Bacterial recolonization
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Experimenteel: Non-hospital group
Non-hospital volunteers who agreed to participate were asked to perform a surgical hand disinfection accordingly to clinic routine.
When hands were dry cultures were first obtained at 3 sites, using a moist with saline nylon flocked swab (Copan ESwab, Italia SpA).
After hand disinfection; 1) in right hand palm, 2) between index finger and middle finger, 3) nail/cuticle of index finger.
This group whore gowns and gloves for approximately 2-3 hours but not kept sterile.
The Culture at the glove cuff were left out.
When gloves were removed cultures were taken again at three sites on the hand.
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Bacterial recolonization
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Leakage from gloves at the glove cuff site as bacterial growth cfu/mL
Tijdsspanne: 3 to 4 hours
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Cultures taken after hand wash and after wearing surgical gloves for about 3 hours
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3 to 4 hours
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Differences between hand flora and its recolonisation, between hospital staff and non-hospital persons showed as bacterial growth, cfu/mL.
Tijdsspanne: 2-3 hours
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Cultures taken after hand wash and after wearing surgical gloves for about 3 hours
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2-3 hours
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Camilla Wistrand, phd student, Örebro University, Sweden
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 februari 2014
Primaire voltooiing (Werkelijk)
1 mei 2015
Studie voltooiing (Werkelijk)
1 mei 2015
Studieregistratiedata
Eerst ingediend
21 januari 2015
Eerst ingediend dat voldeed aan de QC-criteria
9 februari 2015
Eerst geplaatst (Schatting)
10 februari 2015
Updates van studierecords
Laatste update geplaatst (Werkelijk)
4 april 2017
Laatste update ingediend die voldeed aan QC-criteria
3 april 2017
Laatst geverifieerd
1 april 2017
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- glovecuff2014
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .