Skin Cleansing With Chlorhexidine to Decrease Hospital Acquired Infections

June 14, 2023 updated by: Pamela Gonzalez Sr Director Clinical Research Office, Cook County Health

Skin Cleansing With Chlorhexidine to Improve Nosocomial Infection Risks. (SCCIN Project)

Patients in the intensive care unit are at risk for many infections because the severity of illness and the procedures necessary to care for them. This study is designed to look at a change in bathing procedure as a method to reduce infections. Currently, patients at John H. Stroger Hospital are cleansed with soap and water. However, preliminary data from a previous study at Rush University Medical Center showed that a chlorhexidine (CHG)-impregnated cloth (2% CHG Antiseptic Cloth system, Sage Products, Inc.) decreased skin bacteria and may lessen bacteria in the blood stream. The 2% CHG Antiseptic Cloth system is a non-irritating, no-rinse, cleansing and moisturizing product that contains 2% chlorhexidine gluconate. The goal of this proposed study is to further evaluate the effectiveness of the 2% CHG Antiseptic Cloth system compared with soap and water in cleansing the skin and preventing bacteria from entering the bloodstream.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients admitted to the medical intensive care unit at John H Stroger Hospital are randomly assigned to Unit A or B. Unit B was randomly selected as the intervention unit. For 6 months, all patients in Unit B will be bathed with the 2% CHG Antiseptic Cloth system and all patients in Unit A will receive soap and water baths. After this 6 month period, there will be a 2 to 4 week washout period and the interventions will cross over, with Unit A receiving Chlorhexidine baths and unit B receiving soap and water for 6 months.

Each week, two randomly selected patients will have cultures of the inguinal area, neck/subclavian region, and endotracheal aspirates. A comparison of the colonization of the skin and sputum will be done between the two intervention groups.

Daily infection surveillance will be done on all patients in the intensive care unit. A comparison of blood stream infections, clinical sepsis, and other nosocomial infections will be done between the two intervention groups.

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • John H. Stroger Hospital of Cook County

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Data collection will be compiled from all the participants admitted to the Medical Intensive Care Unit (MICU).
  • For skin cultures: One randomly selected (intubated or non-intubated) patient in each intervention group

Exclusion Criteria:

  • Patients with greater than 20% of body surface area disruption in skin integrity will be excluded from participation in the 2% CHG Antiseptic Cloths arm of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: chlorhexidine gluconate (CHG)
daily skin cleansing with no-rinse, 2% CHG-impregnated cloths (Sage)
Drug: 2% chlorhexidine gluconate impregnated cloth
Active Comparator: Soap & Water
bathing daily with bar soap (Dial Corp., Scottsdale, AZ) warm water, and cotton washcloths
Other: Daily bathing with Bar soap
bathed daily with bar soap (Dial Corp., Scottsdale, AZ), warm water, and cotton washcloths.
Other Names:
  • Soap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical: Primary blood stream infections and culture negative sepsis
Time Frame: Six Months
Weekly culture of central line insertion sites
Six Months
Microbiologic: Skin colonization from environment and endotracheal secretions
Time Frame: Six Months
Weekly skin cultures
Six Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical: Laboratory confirmed blood stream infections
Time Frame: Six months
Culture positive blood stream infection from patients on investigational units
Six months
Nosocomial infections
Time Frame: Six months
Positive microbiology lab results of Clostridium difficile-associated diarrhea (CDAD), secondary bloodstream infection (BSI), ventilator-associated pneumonia (VAP), urinary tract infection (UTI), and clinical cultures that grew selected resistant bacteria (MRSA, VRE, and A. baumannii).
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook County Health

Collaborators

Centers for Disease Control and Prevention
Sage Products, Inc.

Investigators

  • Principal Investigator: Robert A Weinstein, MD, John H. Stroger Hospital of Cook County

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

July 26, 2006

Study Registration Dates

First Submitted

August 12, 2005

First Submitted That Met QC Criteria

August 12, 2005

First Posted (Estimated)

August 15, 2005

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 14, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-006
  • IND # 71,948

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pneumonia

Clinical Trials on 2% chlorhexidine gluconate impregnated cloth

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe