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

Primary Purpose

Chlorhexidine, Hospital-Acquired Infection, Surgery

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
2% Chlorhexidine bathing
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chlorhexidine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhongshan Hospital, Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control arm

Intervention arm

Arm Description

Patients were daily bathed with soap and water only.

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

Outcomes

Primary Outcome Measures

Incidence of hospital-acquired infections
Including bloodstream infections (BSI), central line-associated BSI (CLABSI), ventilator-associated pneumonia (VAP) and catheter-associated urinary tract infection (CAUTI).

Secondary Outcome Measures

Multidrug-resistant bacterial colonization free time
Time that the swab samples collected from axilla and groin were persistently negative for target MDR throughout ICU admission.

Full Information

First Posted
November 21, 2021
Last Updated
December 13, 2021
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05142969
Brief Title
Chlorhexidine Bathing to Prevent Hospital-acquired Infections: the CLEANS Study
Official Title
Effect of Chlorhexidine Bathing on Prevention of Hospital-Acquired Infections in Patients After Surgery in ICU: A Prospective, Single-Center, Single-Blind, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chlorhexidine, Hospital-Acquired Infection, Surgery, Intensive Care Unit

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
247 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Patients were daily bathed with soap and water only.
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Patients were daily bathed with soap and water and then receive 2% Chlorhexidine bathing (Petel Skin care wipes, Likang LtD, shanghai, China).
Intervention Type
Other
Intervention Name(s)
2% Chlorhexidine bathing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of hospital-acquired infections
Description
Including bloodstream infections (BSI), central line-associated BSI (CLABSI), ventilator-associated pneumonia (VAP) and catheter-associated urinary tract infection (CAUTI).
Time Frame
throughout study completion, an average of 7 days
Secondary Outcome Measure Information:
Title
Multidrug-resistant bacterial colonization free time
Description
Time that the swab samples collected from axilla and groin were persistently negative for target MDR throughout ICU admission.
Time Frame
throughout study completion, an average of 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shining Cai, PhD
Phone
02164041990
Email
cai.shining@zs-hospital.sh.cn
Facility Information:
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shining Cai

12. IPD Sharing Statement

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

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