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Chlorhexidine Bathing to Prevent Hospital-acquired Infections: the CLEANS Study

NCT ID: NCT05142969

Last Updated: 2021-12-29

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

NA

Total Enrollment

247 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-12-31

Brief Summary

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Hospital-acquired infections (HAI) have been shown to increase length of hospital stay and mortality. Infections acquired during a hospital stay have been shown to be preventable. The skin of patients is considered a major reservoir for pathogens associated with hospital-acquired infections, and has been suggested as a potential target for interventions to reduce bacterial burden and subsequent risk of infection. The use of daily Chlorhexidine (CHG) bathing in intensive care patients has been advocated to reduce many of the infections in critically ill patients. However, the effectiveness of CHG bathing to reduce ICU infections has varied considerably among published trials, making the effectiveness of CHG bathing in ICU patients uncertain.

Detailed Description

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Conditions

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Chlorhexidine Hospital-Acquired Infection Surgery Intensive Care Unit

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control arm

Patients were daily bathed with soap and water only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention arm

Patients were daily bathed with soap and water and then receive 2% Chlorhexidine bathing (Petel Skin care wipes, Likang LtD, shanghai, China).

Group Type EXPERIMENTAL

2% Chlorhexidine bathing

Intervention Type OTHER

Eight chlorhexidine-impregnated cloths are used in sequential order to wipe the body surfaces from neck to toe to avoid exposure of chlorhexidine to the mucous membranes of the eyes, ears and mouth.

Interventions

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2% Chlorhexidine bathing

Eight chlorhexidine-impregnated cloths are used in sequential order to wipe the body surfaces from neck to toe to avoid exposure of chlorhexidine to the mucous membranes of the eyes, ears and mouth.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* adults (≥ 18-years old)
* anticipated SICU stay for 48 hours or more
* APACHE II \>15

Exclusion Criteria

* Braden Scale for Predicting Pressure Sore Risk score more than 9 (highest risk)
* pregnancy
* skin irritation
* chlorhexidine allergy
* SICU stay of more than 48 hours prior to screening
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shining Cai, PhD

Role: CONTACT

Phone: 02164041990

Email: [email protected]

Facility Contacts

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Shining Cai

Role: primary

Other Identifiers

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2020ZSLC69

Identifier Type: -

Identifier Source: org_study_id