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Completed

NCT Number: NCT02359708

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Örbro university hospital

Örebro, 701 85, Sweden

About this study

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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical hand disinfection.

Procedure

Bacterial recolonization

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 10, 2015
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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