NCT02359708

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

April 4, 2017

Status Verified

April 1, 2017

Enrollment Period

1.2 years

First QC Date

January 21, 2015

Last Update Submit

April 3, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Differences between hand flora and its recolonisation, between hospital staff and non-hospital persons showed as bacterial growth, cfu/mL.

    2-3 hours

Study Arms (2)

OR nurse group

EXPERIMENTAL

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.

Non-hospital group

EXPERIMENTAL

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.

Interventions

Bacterial recolonization

Non-hospital groupOR nurse group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Operating nurse at the department and non-hospital persons

You may not qualify if:

  • Participated previously in present study
  • Use of gloves with antimicrobial effect
  • Patient with a known infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Örbro university hospital

Örebro, 701 85, Sweden

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Hand Disinfection

Intervention Hierarchy (Ancestors)

Hand HygieneHygienePublic HealthEnvironment and Public Health

Study Officials

  • Camilla Wistrand, phd student

    Örebro University, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Operating room nurse

Study Record Dates

First Submitted

January 21, 2015

First Posted

February 10, 2015

Study Start

February 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

April 4, 2017

Record last verified: 2017-04

Locations