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Multicenter Evaluation of The Effectiveness of Source Control With Daily Chlorhexidine Skin Preparation in Reducing Nosocomial Infections Including MRSA and VRE


N/A
18 Years
N/A
Open (Enrolling)
Both
Nosocomial Bacteremia, MRSA Colonization, MRSA Infection, VRE Colonization, VRE Infection

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Trial Information

Multicenter Evaluation of The Effectiveness of Source Control With Daily Chlorhexidine Skin Preparation in Reducing Nosocomial Infections Including MRSA and VRE


This is a cluster randomized, crossover-controlled trial with wards as the units of
randomization. The trial will predominantly take place in ICU's but may include any acute
care ward that has active surveillance for MRSA and or VRE in place (i.e., Bone Marrow
transplant units, Oncology wards, etc.) Units will be randomly assigned to utilize two
bathing routines in a random order. Each bathing routine will be utilized on all admitted
patients to the unit for a six month study period for a total study duration of 12 months.
The two bathing routines will include either the use of the Comfort® Bath Washcloth System
(control) or the use of 2% Chlorhexidine Gluconate Cloth. Randomized units will either start
with 2% Chlorhexidine Gluconate Cloth for six months and then switch to Comfort™ Bath
Washcloth for the remaining six month period or the reverse order. Data collection will
include all surveillance and clinical cultures for MRSA and or VRE and all bloodstream
infections.


Inclusion Criteria:



- All patients admitted to study units during the proposed study interval are eligible
for inclusion in the study

Exclusion Criteria:

- Patients with known allergies to chlorhexidine gluconate or any other ingredients in
the product

- Patients with burns that include a high percentage of disrupted body surface area

- Use in patients undergoing lumbar punctures or contact with the meninges

- Patients with large open skin wounds; and

- Children less than 18 years old

Type of Study:

Observational

Study Design:

Observational Model: Defined Population, Observational Model: Natural History, Time Perspective: Longitudinal, Time Perspective: Prospective

Principal Investigator

Michael W Climo, MD

Investigator Role:

Study Director

Investigator Affiliation:

Hunter Holmes Mcguire Veteran Affairs Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

CI06-003

NCT ID:

NCT00502476

Start Date:

August 2007

Completion Date:

September 2009

Related Keywords:

  • Nosocomial Bacteremia
  • MRSA Colonization
  • MRSA Infection
  • VRE Colonization
  • VRE Infection
  • MRSA
  • VRE
  • BSI
  • Bacteremia
  • Cross Infection
  • Staphylococcal Infections

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Northwestern Memorial HospitalChicago, Illinois  60611
Brigham and Women's HospitalBoston, Massachusetts  02115
Barnes Jewish HospitalSt. Louis, Missouri  63110
Johns Hopkins HospitalBaltimore, Maryland  21287
Hunter Holmes McGuire Veteran Affairs Medical CenterRichmond, Virginia  23249