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Drying of endoscopes with PlasmaTYPHOON

Drying of endoscopes with PlasmaTYPHOON - Typhoon Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00025582
Enrollment
616
Registered
2021-06-23
Start date
2021-12-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

bacterial count in the working channels of endoscopes residual liquid in endoscopes after termination of drying process

Interventions

Group 1: Intervention group: drying of the endoscopes with a novel method (PlasmaTYPHOON) followed by manual drying with compressed air. Group 2: Control group (drying of the endoscopes in the cleanin

Sponsors

Pentax Medical
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Endoscopes that were used in the course of an examination on a patient in the endoscopy department of a university hospital 2.Endoscopes that have undergone the entire reprocessing process (depending on the study group).

Exclusion criteria

Exclusion criteria: 1. No endoscopic examination being performed at a patient (e.g. termination of the endoscopy before the start of the examination due to restricted cardiorespiratory situation of the patient, although the endoscope was already in the examination room). 2.Incomplete reprocessing (e.g. positive leak test). 3.Reuse of the endoscope before completion of the storage interval according to the present study protocol (in this case, the endoscope can be used at least in an intention-to-treat analysis for the samples already collected)

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is the distribution of the qualitative bacterial count (detectable versus absent) on the respective day of sampling in comparison between control and intervention group. Samples are taken as a pooled sample from all endoscopic channels. Microbiological cultivation and evaluation of the samples is performed by qualified staff of the Institute of Medical Microbiology and Hospital Hygiene, Hygiene Laboratory.

Secondary

MeasureTime frame
The secondary outcome measures are as follows: -Distribution of quantitative microbial count by colony forming unit (CFU) on the respective day of sampling in comparison between control and intervention group. -Distribution of wet germs (qualitative [detectable versus absent] and quantitative by colony forming unit (CFU) in comparison between control and intervention group. Evaluation of qualitative/quantitative moisture detection after mechanical drying (control group) versus drying by PlasmaTYPHOON (intervention group). -Duration of drying compared between control and intervention group. -Absolute and relative risk reduction of microbial colonization compared between control and intervention groups.

Countries

Germany

Contacts

Public ContactMireen Friedrich-Rust

Universitätsklinikum FrankfurtMedizinische Klinik 1

Mireen.Friedrich-Rust@kgu.de0049-69-6301-5333

Outcome results

None listed

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