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NCT Number: NCT00130221

Skin Cleansing With Chlorhexidine to Decrease Hospital Acquired Infections

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.

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Key information

Conditions

Nosocomial Infection Bacteremia Bacterial Infections Bacterial Infections and Mycoses Clostridium Infection Clostridium Infections Cross Infection Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gram-Positive Bacterial Infections Healthcare-Associated Pneumonia Iatrogenic Disease Infections Inflammation Lung Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Sepsis Systemic Inflammatory Response Syndrome Urinary Tract Infection Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

John H. Stroger Hospital of Cook County

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2% chlorhexidine gluconate impregnated cloth

Drug

Daily bathing with Bar soap

Other

bathed daily with bar soap (Dial Corp., Scottsdale, AZ), warm water, and cotton washcloths.

Other names: Soap

Primary outcomes

  1. Clinical: Primary blood stream infections and culture negative sepsis

    Time frame: Six Months

    Weekly culture of central line insertion sites

  2. Microbiologic: Skin colonization from environment and endotracheal secretions

    Time frame: Six Months

    Weekly skin cultures

Secondary outcomes

  1. Clinical: Laboratory confirmed blood stream infections

    Time frame: Six months

    Culture positive blood stream infection from patients on investigational units

  2. 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).

Sponsors and collaborators

Lead sponsor

Cook County Health

Other Gov

Collaborators

  • Centers for Disease Control and Prevention
  • Sage Products, Inc.

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Aug 15, 2005
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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