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Recolonisation of Bacteria in Hands and Possible Bacterial Leakage From Glove Cuff in Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT02359708
Recruitment Status : Completed
First Posted : February 10, 2015
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Camilla Wistrand, Örebro University, Sweden

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bacterial Growth Procedure: Surgical hand disinfection. Not Applicable

Detailed Description:
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?

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: 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.
Study Start Date : February 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: 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.
Procedure: Surgical hand disinfection.
Bacterial recolonization

Experimental: 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.
Procedure: Surgical hand disinfection.
Bacterial recolonization




Primary Outcome Measures :
  1. Leakage from gloves at the glove cuff site as bacterial growth cfu/mL [ Time Frame: 3 to 4 hours ]
    Cultures taken after hand wash and after wearing surgical gloves for about 3 hours


Secondary Outcome Measures :
  1. Differences between hand flora and its recolonisation, between hospital staff and non-hospital persons showed as bacterial growth, cfu/mL. [ Time Frame: 2-3 hours ]
    Cultures taken after hand wash and after wearing surgical gloves for about 3 hours



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02359708


Locations
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Sweden
Örbro university hospital
Örebro, Sweden, 701 85
Sponsors and Collaborators
Örebro University, Sweden
Investigators
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Principal Investigator: Camilla Wistrand, phd student Örebro University, Sweden
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Camilla Wistrand, Operating room nurse, Örebro University, Sweden
ClinicalTrials.gov Identifier: NCT02359708    
Other Study ID Numbers: glovecuff2014
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: April 2017