NCT06566495

Brief 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

July 25, 2024

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 22, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

August 14, 2024

Last Update Submit

August 19, 2024

Conditions

Keywords

TourniquetCross InfectionVascular Access DevicesInfection Control

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    24 hours

Secondary Outcomes (1)

  • Blood stains and CFU

    2 months

Study Arms (3)

reusable tourniquets used by indefinite time

6 tourniquets from emergency department and 11 tourniquets from operating theatre

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

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

Device: collection of microbiological material from reusable tourniquets

Interventions

Microbiological analysis The material was collected in each group in the same way.

Also known as: sampling of microbiological material
reusable tourniquets used by 14 daysreusable tourniquets used by 28 daysreusable tourniquets used by indefinite time

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

53 reusable tourniquets

You may qualify if:

  • reusable tourniquets used to make the vessel visible

You may not qualify if:

  • disposable tourniquets used to make the vessel visible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Univeristy of Gdańsk

Gdansk, Dębinki Street, 80-211, Poland

Location

MeSH Terms

Conditions

Communicable DiseasesBacterial InfectionsCross Infection

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBacterial Infections and MycosesIatrogenic Disease

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2024

First Posted

August 22, 2024

Study Start

July 25, 2024

Primary Completion

December 1, 2024

Study Completion

December 31, 2024

Last Updated

August 22, 2024

Record last verified: 2024-08

Locations