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Controlled Crossover Study of AIONX Antimicrobial Surface for the Prevention of Healthcare-associated Infections

NCT ID: NCT03189043

Last Updated: 2017-06-16

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

10000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2017-10-01

Brief Summary

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This is a controlled open label efficacy study of Aionx antimicrobial surface for the prevention of healthcare-associated infections.

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Detailed Description

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The study is an open label controlled efficacy trial of Aionx patented antimicrobial surface for the prevention of healthcare-associated infections (HAIs). It will take place at Penn State Hershey. Half of the single occupancy rooms of the 5th and 7th floor will be assigned to contain the antimicrobial surface at five locations: bed rails, overbed table, door handles, counter, and arm rests of bedside chair. The remaining rooms will serve as controls. Data on HAIs will be gathered for all the patients admitted to the rooms during the duration of the study. After 45 days the rooms will be flipped so that test rooms become controls and control rooms become test rooms. The duration of the study will be for a minimum of 90 days.

Conditions

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Healthcare Associated Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Test

Use of antimicrobial surface

Group Type EXPERIMENTAL

Antimicrobial Surface

Intervention Type DEVICE

Antimicrobial Surface

Control

No antimicrobial surface

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Antimicrobial Surface

Antimicrobial Surface

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Admission to a single occupancy room in a participating floor at Hershey Medical Center

Exclusion Criteria

* Refusal to participate in the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aionx, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Dr. Jose Stoute

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jose A Stoute, M.D.

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Central Contacts

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Jose A Stoute, M.D.

Role: CONTACT

[email protected]
3017583689

Other Identifiers

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7371

Identifier Type: -

Identifier Source: org_study_id

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