Cleaning Efficacy of Pulsed Vacuum Device on Rigid Endoscopic Instruments

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2024-12-31

Brief Summary

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This study is a prospective, comparative trial designed to evaluate the cleaning effectiveness of a novel pulsed vacuum cleaning and disinfection device against a conventional vacuum ultrasonic cleaner for rigid endoscopic instruments. Key outcomes measured include cleaning time, cleaning quality (via visual, light source, and ATP inspection), protein residue levels, and instrument damage rate.

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Detailed Description

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Rigid endoscopic instruments, due to their complex structure, pose significant challenges for cleaning and sterilization, which is critical for preventing hospital-acquired infections. Traditional methods like ultrasonic and spray cleaning have limitations in efficiency and thoroughness. This study was conducted to assess a newer technology, the pulsed vacuum cleaning and disinfection device, which integrates cleaning, rinsing, disinfection, and drying. A total of 800 rigid endoscopic instruments were divided into two groups: one cleaned with the pulsed vacuum device (Observation Group) and the other with a conventional vacuum ultrasonic cleaner (Control Group). The study aims to provide evidence-based insights into the efficiency, efficacy, and safety of the pulsed vacuum device for clinical application in sterilization supply centers.

Conditions

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Post-Surgical Contamination of Rigid Endoscopic Instruments

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pulsed Vacuum Cleaning Group

A total of 400 rigid endoscopic instruments were cleaned using a pulsed vacuum cleaning and disinfection device following manual pre-treatment. The process integrated cleaning, rinsing, disinfection, and vacuum drying into a single automated cycle.

Group Type EXPERIMENTAL

Pulsed Vacuum Cleaning and Disinfection Device

Intervention Type DEVICE

After manual pre-treatment, instruments were placed into the pulsed vacuum cleaning and disinfection machine (Shandong Xinhua Medical, Model PC-150L). The automated program included pulsed vacuum cleaning, rinsing, thermal disinfection (93°C for 2.5 minutes), and vacuum drying.

Ultrasonic Cleaning Group

A total of 400 rigid endoscopic instruments were cleaned using a conventional vacuum ultrasonic cleaner, followed by a separate spray cleaning and drying process, after manual pre-treatment.

Group Type ACTIVE_COMPARATOR

Vacuum Ultrasonic Cleaner

Intervention Type DEVICE

After manual pre-treatment, instruments were cleaned in a vacuum ultrasonic cleaner (Shandong Xinhua Medical, Model super-6000) with a multi-enzyme solution for a minimum of 5 minutes. This was followed by a separate process in a spray cleaning and disinfection machine for rinsing and drying.

Interventions

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Pulsed Vacuum Cleaning and Disinfection Device

After manual pre-treatment, instruments were placed into the pulsed vacuum cleaning and disinfection machine (Shandong Xinhua Medical, Model PC-150L). The automated program included pulsed vacuum cleaning, rinsing, thermal disinfection (93°C for 2.5 minutes), and vacuum drying.

Intervention Type DEVICE

Vacuum Ultrasonic Cleaner

After manual pre-treatment, instruments were cleaned in a vacuum ultrasonic cleaner (Shandong Xinhua Medical, Model super-6000) with a multi-enzyme solution for a minimum of 5 minutes. This was followed by a separate process in a spray cleaning and disinfection machine for rinsing and drying.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Rigid endoscopic instruments scheduled for post-operative cleaning.
* Types of instruments included: laparoscopes, hysteroscopes, arthroscopes, nephroscopes, prostate resection scopes, and thoracoscopes.

Eligible Sex

ALL

Accepts Healthy Volunteers

No