Bacterial GrowthNCT02359708
Recolonisation of Bacteria in Hands and Possible Bacterial Leakage From Glove Cuff in Cardiac Surgery
A study testing Surgical hand disinfection. in people with Bacterial Growth, run by Örebro University, Sweden at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bacterial Growth
- What is being tested?
- Surgical hand disinfection.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Operating nurse at the department and non-hospital persons
Who cannot join
- Participated previously in present study
- Use of gloves with antimicrobial effect
- Patient with a known infection
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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?
- Conditions
- Bacterial Growth
- Being tested
- Surgical hand disinfection.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical hand disinfection.Procedure or surgery
Bacterial recolonization
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Surgical hand disinfection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Cultures taken after hand wash and after wearing surgical gloves for about 3 hours
Measured: 2-3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startFeb 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bacterial GrowthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camilla Wistrand, Örebro University, Sweden
- Investigators
- Camilla Wistrand, phd student, Principal investigator, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359708
- Sponsor's protocol ID
- glovecuff2014
- Status last verified
- Apr 2017
- First submitted
- 21 Jan 2015
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30223772
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02359708
- Acronym / sponsor ID
- glovecuff2014
- Conditions
- Bacterial Growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OR nurse group | Experimental | Procedure: Surgical hand disinfection.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. |
| Non-hospital group | Experimental | Procedure: Surgical hand disinfection.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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Operating nurse at the department and non-hospital persons
Key exclusion criteria (3 listed)
- Participated previously in present study
- Use of gloves with antimicrobial effect
- Patient with a known infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical hand disinfection.Bacterial recolonization | Procedure or surgery | Non-hospital group, OR nurse group |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Derived from this study: PubMed 30223772Wistrand 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camilla Wistrand, phd student principal investigator
Örebro University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical hand disinfection. in people with Bacterial Growth, run by Örebro University, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leakage from gloves at the glove cuff site as bacterial growth cfu/mL (time frame: 3 to 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02359708, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.