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robustness of desinfected nitril gloves in simulated cardiopulmonary ressucitation - an experimental mankin simulationstudy

robustness of desinfected nitril gloves in simulated cardiopulmonary ressucitation - an experimental mankin simulationstudy - GLOVDIS-2

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00036508
Enrollment
16
Registered
2025-04-01
Start date
2025-08-02
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The aim is to investigate whether disinfected and non-disinfected gloves leak more frequently in one arm during simulated Basic and Avance Life Support measures I46.0

Interventions

Group 1: Test for robustness of not desinfected examination gloves according to DIN EN 455-1:2024-11 Group 2: Test for robustness of 85% ethanol desinfected examination gloves according to DIN EN 455-

Sponsors

Paul Hartmann AG
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Age of majority - Freely given consent to the study - Completed 3-year training in a healthcare profession and related to emergency medicine (e.g. physicians, rescue service personnel (emergency paramedics, paramedics), healthcare and nursing staff, anesthesia technicians, physician assistants) as well as medical students in their practical year.

Exclusion criteria

Exclusion criteria: - Rejection of the study - Long fingernails (above fingertip level), - Wearing nail jewelry - Wearing finger rings potentially damaging the glove* - Wearing watches potentially damaging the glove* - Dermatological diseases of the hands and intolerance to the disinfectant or nitrile substances used. *Criterion adopted after recruitment but prior to data analysis. Amendments are explored in statistics and will be reported according to the ICH guidelines. Initially: "Wearing finger rings" / "Wearing watches" ---> Information of the Ethical Board on 26/08/2025 (see Amendment response 03/09/2025

Design outcomes

Primary

MeasureTime frame
The end point is the detection of damage to the glove used after a measure (simulated life support action according to BLS or ACLS) by testing in accordance with DIN EN 455-1_2024-11.

Secondary

MeasureTime frame
explorative analysis

Countries

Germany

Contacts

Public ContactStefan Bushuven

NOTIS e.V.

Stefan.Bushuven@notis-ev.de+4917630376597

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026