- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02359708
Recolonisation of Bacteria in Hands and Possible Bacterial Leakage From Glove Cuff in Cardiac Surgery
3. april 2017 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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?
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
28
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Örebro, Sverige, 701 85
- Örbro university hospital
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Leakage from gloves at the glove cuff site as bacterial growth cfu/mL
Tidsramme: 3 to 4 hours
|
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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Differences between hand flora and its recolonisation, between hospital staff and non-hospital persons showed as bacterial growth, cfu/mL.
Tidsramme: 2-3 hours
|
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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Camilla Wistrand, phd student, Örebro University, Sweden
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2014
Primær færdiggørelse (Faktiske)
1. maj 2015
Studieafslutning (Faktiske)
1. maj 2015
Datoer for studieregistrering
Først indsendt
21. januar 2015
Først indsendt, der opfyldte QC-kriterier
9. februar 2015
Først opslået (Skøn)
10. februar 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. april 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. april 2017
Sidst verificeret
1. april 2017
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- glovecuff2014
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .