Microbial ColonizationNCT06566495
Microorganisms on Reusable Tourniquets
An observational study of Microbial Colonization and Infection, Bacterial, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
The purpose of this study was to compare microbial contamination on the surface of reusable stasis after indefinite use, 2 weeks and 4 weeks. We investigated how the site - the operating theater and the emergency department, as well as the time of use - affects the number of organisms. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Microbial Colonization, Infection, Bacterial, HAI
- What is being tested?
- collection of microbiological material from reusable tourniquets
- Type of treatment
- Medical device
- How many people
- 53 participants
- Where
- 1 sitePoland
- Study dates
- 25 Jul 2024to 31 Dec 2024
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: 53 reusable tourniquets
Who may be able to join
- reusable tourniquets used to make the vessel visible
Who cannot join
- disposable tourniquets used to make the vessel visible
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reusable Tourniquets as Potential Risk of Microbial Transmission - Comparison of Operating Theatre and Emergency Department
The purpose of this study was to compare microbial contamination on the surface of reusable stasis after indefinite use, 2 weeks and 4 weeks. We investigated how the site - the operating theater and the emergency department, as well as the time of use - affects the number of organisms.
Read the detailed description
The cross-sectional study was conducted in the operating theater and emergency department of a tertiary referral hospital in Gdansk, Poland, in three part from March to April 2024. The study included reusable tourniquets used by the hospital's medical staff during vascular access generation.
After each stage of the in-hospital study, the stasis was collected and replaced with new ones. A total of 53 reusable stasis were collected in three phases of the study and were subjected to microbiological analysis at the Department of Immunobiology and Environmental Microbiology of the Medical University of Gdansk. The tourniquets were collected into disposable, sterile bags. In the first stage of the study, tourniquets were collected of indefinite use (n= 17). In the second and third stages of the study, stasis used for 14 (n=20) and 28 (n=16) days, respectively, were collected. All tourniquets were labeled and assigned to different rooms located within the surveyed wards. The trial was conducted separately, for the plastic fastener and the fabric band. The plastic parts of the tourniquets were placed in sterile glass dishes. Under laboratory conditions, the plastic parts of the stasis were cut off and placed in the dishes. Using sterile swabs soaked in 0.9% sodium chloride, the plastic was swabbed, after which the tip of the swab was cut off, placed in a tube with 0.9% sodium chloride (3ml), which was shaken in a Vortex device (30 seconds) and the obtained material was seeded on columbia Agar with 5% sheep blood. The material part of the stasis was placed in a sterile homogenization bag with the addition of 100ml of nutrient broth. The bag was then placed in a Stomacher Homogenizer for two minutes to detach the microorganisms from the porous surface of the material. The resulting homogenate was transferred in a concentrated state and diluted tenfold using 200 μl pipettes onto columbia Agar media supplemented with 5% sheep blood.200 μl of concentrated homogenate was seeded onto the quality growth media MacConkey Broth, King B Agar, CHROMagar E. coli and other coliforms. The protected material was incubated for 24 hours at 37°C, in an aerobic atmosphere. After this time, bacterial colonies were counted and counts were performed to determine the number of microorganisms on the surface of the stasis (CFU/cm2). Due to the assumptions of the experiment and the time frame, eight tourniquets were not included in the analysis. From the information obtained from the medical staff, this was due to significant soiling, making it impossible to use the tourniquets, and in a few cases the plastic fastener broke.
- Conditions
- Microbial Colonization, Infection, Bacterial, HAI, Nurse's Role, Vascular Access Device Complications, Vascular Access Complication
- Being tested
- collection of microbiological material from reusable tourniquets
- Keywords
- Tourniquet, Cross Infection, Vascular Access Devices, Infection Control
- Medical subject headings
- Communicable Diseases, Bacterial Infections, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of microbiological material from reusable tourniquetsDevice
Also called sampling of microbiological material
Microbiological analysis
The material was collected in each group in the same way.
| Study group | Role | What they receive |
|---|---|---|
| reusable tourniquets used by indefinite time | 6 tourniquets from emergency department and 11 tourniquets from operating theatre Receives: Device: collection of microbiological material from reusable tourniquets | |
| reusable tourniquets used by 14 days | 6 tourniquets from emergency department and 14 tourniquets from operating theatre Receives: Device: collection of microbiological material from reusable tourniquets | |
| reusable tourniquets used by 28 days | 6 tourniquets from emergency department and 10 tourniquets from operating theatre Receives: Device: collection of microbiological material from reusable tourniquets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard Deviation and median of colony forming units (CFU/cm2) in the emergency department
After 24h incubation at 37 deg C, we evaluated the number of bacterial colony-forming colonies on leaf and quality plates. The average number of CFU/cm2 in all stages of the study for the emergency department is 19,110, 34 CFU/cm2. For the MCC substrate for the emergency department medium 227.65; standard deviation 102.75 CFU/cm2. For the King B substrate for the emergency department medium 241.71, standard deviation 115.15 18 CFU/cm2. There is no statistically significant difference for OD versus CFU/cm2 during the second and third intake. There were no bacterial growth was obtained on the ECC plate.
Measured: 24 hours
Standard Deviation and median of colony forming units (CFU/cm2) in the operating theatre
After 24h incubation at 37 deg C, we evaluated the number of bacterial colony-forming colonies on leaf and quality plates. The average number of CFU/cm2 in all stages of the study for the operating theatre was 88.27 CFU/cm2. For the MCC substrate for the operating theatre medium 14.18 standard deviation 24.06 CFU/cm2. For the King B substrate for the operating theatre medium 33.07 standard deviation 65.18 CFU/cm2.There is no statistically significant difference for OD versus CFU/cm2 during the second and third intake. There were no bacterial growth was obtained on the ECC plate.
Measured: 24 hours
Secondary outcomes (1)
Blood stains and CFU
23 of 53 examined tourniquets (43%), 12/18 (67%) from the emergency department and 11/35 (31%) from the operating theatre had visible blood stains. Blood stains did not affect the number of colony-forming units (CFUs).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start25 Jul 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566495
- Sponsor's protocol ID
- KB/45/2024
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reusable Tourniquets as Potential Risk of Microbial Transmission - Comparison of Operating Theatre and Emergency Department
- ClinicalTrials.gov ID
- NCT06566495
- Acronym / sponsor ID
- KB/45/2024
- Conditions
- Microbial Colonization, Infection, Bacterial, HAI, Nurse's Role, Vascular Access Device Complications, Vascular Access Complication
- Keywords
- Tourniquet, Cross Infection, Vascular Access Devices, Infection Control
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Aug 2024 (actual)
- 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.
The purpose of this study was to compare microbial contamination on the surface of reusable stasis after indefinite use, 2 weeks and 4 weeks. We investigated how the site - the operating theater and the emergency department, as well as the time of use - affects the number of organisms.
Detailed description
The cross-sectional study was conducted in the operating theater and emergency department of a tertiary referral hospital in Gdansk, Poland, in three part from March to April 2024. The study included reusable tourniquets used by the hospital's medical staff during vascular access generation.
After each stage of the in-hospital study, the stasis was collected and replaced with new ones. A total of 53 reusable stasis were collected in three phases of the study and were subjected to microbiological analysis at the Department of Immunobiology and Environmental Microbiology of the Medical University of Gdansk. The tourniquets were collected into disposable, sterile bags. In the first stage of the study, tourniquets were collected of indefinite use (n= 17). In the second and third stages of the study, stasis used for 14 (n=20) and 28 (n=16) days, respectively, were collected. All tourniquets were labeled and assigned to different rooms located within the surveyed wards. The trial was conducted separately, for the plastic fastener and the fabric band. The plastic parts of the tourniquets were placed in sterile glass dishes. Under laboratory conditions, the plastic parts of the stasis were cut off and placed in the dishes. Using sterile swabs soaked in 0.9% sodium chloride, the plastic was swabbed, after which the tip of the swab was cut off, placed in a tube with 0.9% sodium chloride (3ml), which was shaken in a Vortex device (30 seconds) and the obtained material was seeded on columbia Agar with 5% sheep blood. The material part of the stasis was placed in a sterile homogenization bag with the addition of 100ml of nutrient broth. The bag was then placed in a Stomacher Homogenizer for two minutes to detach the microorganisms from the porous surface of the material. The resulting homogenate was transferred in a concentrated state and diluted tenfold using 200 μl pipettes onto columbia Agar media supplemented with 5% sheep blood.200 μl of concentrated homogenate was seeded onto the quality growth media MacConkey Broth, King B Agar, CHROMagar E. coli and other coliforms. The protected material was incubated for 24 hours at 37°C, in an aerobic atmosphere. After this time, bacterial colonies were counted and counts were performed to determine the number of microorganisms on the surface of the stasis (CFU/cm2). Due to the assumptions of the experiment and the time frame, eight tourniquets were not included in the analysis. From the information obtained from the medical staff, this was due to significant soiling, making it impossible to use the tourniquets, and in a few cases the plastic fastener broke.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| reusable tourniquets used by indefinite time | – | Device: collection of microbiological material from reusable tourniquets6 tourniquets from emergency department and 11 tourniquets from operating theatre |
| reusable tourniquets used by 14 days | – | Device: collection of microbiological material from reusable tourniquets6 tourniquets from emergency department and 14 tourniquets from operating theatre |
| reusable tourniquets used by 28 days | – | Device: collection of microbiological material from reusable tourniquets6 tourniquets from emergency department and 10 tourniquets from operating theatre |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 53 reusable tourniquets
Key inclusion criteria (1 listed)
- reusable tourniquets used to make the vessel visible
Key exclusion criteria (1 listed)
- disposable tourniquets used to make the vessel visible
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 |
|---|---|---|
| collection of microbiological material from reusable tourniquetsAlso: sampling of microbiological materialMicrobiological analysis The material was collected in each group in the same way. | Device | reusable tourniquets used by 14 days, reusable tourniquets used by 28 days, reusable tourniquets used by indefinite time |
Primary outcome
Standard Deviation and median of colony forming units (CFU/cm2) in the emergency department
Time frame: 24 hours
After 24h incubation at 37 deg C, we evaluated the number of bacterial colony-forming colonies on leaf and quality plates. The average number of CFU/cm2 in all stages of the study for the emergency department is 19,110, 34 CFU/cm2. For the MCC substrate for the emergency department medium 227.65; standard deviation 102.75 CFU/cm2. For the King B substrate for the emergency department medium 241.71, standard deviation 115.15 18 CFU/cm2. There is no statistically significant difference for OD versus CFU/cm2 during the second and third intake. There were no bacterial growth was obtained on the ECC plate.
Standard Deviation and median of colony forming units (CFU/cm2) in the operating theatre
Time frame: 24 hours
After 24h incubation at 37 deg C, we evaluated the number of bacterial colony-forming colonies on leaf and quality plates. The average number of CFU/cm2 in all stages of the study for the operating theatre was 88.27 CFU/cm2. For the MCC substrate for the operating theatre medium 14.18 standard deviation 24.06 CFU/cm2. For the King B substrate for the operating theatre medium 33.07 standard deviation 65.18 CFU/cm2.There is no statistically significant difference for OD versus CFU/cm2 during the second and third intake. There were no bacterial growth was obtained on the ECC plate.
1 secondary outcome
Blood stains and CFU
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
Related trials for Microbial Colonization
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
RecruitingPhase 2/3
Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide
Chronic Hepatitis D
Enrolling by invitationObservational study
Evaluation and Long-Term Follow-up of Patients With Inflammatory Disorders
Inflammation
RecruitingPhase 2
Phase 2 EL219 Versus Liposomal Amphotericin B or Voriconazole for Early Antifungal Therapy
Invasive Mould Infection
Not yet recruiting
Fermented Mare's Milk Supplementation During Acute Viral Respiratory Infection
Acute Respiratory Diseases
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microbial Colonization and Infection, Bacterial, run by Medical University of Gdansk at 1 site in Poland.
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 1 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: status not confirmed, as of the sponsor's last update on 22 Aug 2024. 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 Poland. 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?
Results are not available in the source record.
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?
Standard Deviation and median of colony forming units (CFU/cm2) in the emergency department (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2024.