Clinical trial NCT02359708: Recolonisation of Bacteria in Hands and Possible Bacterial Leakage From Glove Cuff in Cardiac Surgery
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Growth
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
First posted: 2015-02-10
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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?

Eligibility 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

Primary outcomes:
measure: Leakage from gloves at the glove cuff site as bacterial growth cfu/mL
timeFrame: 3 to 4 hours
Secondary outcomes:
measure: Differences between hand flora and its recolonisation, between hospital staff and non-hospital persons showed as bacterial growth, cfu/mL.
timeFrame: 2-3 hours
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Örbro university hospital
Study officials:
affiliation: Örebro University, Sweden
name: Camilla Wistrand, phd student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wistrand C, Soderquist B, Falk-Brynhildsen K, Nilsson U. Exploring bacterial growth and recolonization after preoperative hand disinfection and surgery between operating room nurses and non-health care workers: a pilot study. BMC Infect Dis. 2018 Sep 17;18(1):466. doi: 10.1186/s12879-018-3375-3.