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

Bacterial Growth Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02359708
• Other study ID #: glovecuff2014
• Status: Completed
• Phase: N/A
• First received: January 21, 2015
• Last updated: April 3, 2017
• Start date: February 2014
• Est. completion date: May 2015

Study information

• Verified date: April 2017
• Source: Örebro University, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Growth

Intervention

Procedure:
• Surgical hand disinfection.
Bacterial recolonization

Locations

Country	Name	City	State
Sweden	Örbro university hospital	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Örebro University, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leakage from gloves at the glove cuff site as bacterial growth cfu/mL	Cultures taken after hand wash and after wearing surgical gloves for about 3 hours	3 to 4 hours
Secondary	Differences between hand flora and its recolonisation, between hospital staff and non-hospital persons showed as bacterial growth, cfu/mL.	Cultures taken after hand wash and after wearing surgical gloves for about 3 hours	2-3 hours