Chlorhexidine Impregnated Cloths to Prevent Skin and Soft Tissue Infections in Marine Officer Candidates - Full Text View

Sponsored by:	Uniformed Services University of the Health Sciences
Information provided by:	Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier:	NCT00475930

Purpose

Outbreaks of skin and soft tissue infections (SSTI) related to community associated Methicillin-resistant Staphylococcus aureus (MRSA) have become increasingly common in military training units. Risk factors for MRSA related SSTI such as crowding, poor hygiene and shared equipment are often hard to avoid in a military training environment, often designed to simulate battlefield conditions.

It has recently been demonstrated that military recruits colonized with MRSA may be at increased risk of developing SSTI. Studies in the hospital environment have shown that decolonizing inpatients known to carry MRSA decreases the rates of MRSA related infections in the treated individuals and also in their inpatient unit as a whole.

We propose a randomized, double blind, placebo controlled trial to:

Evaluate the effectiveness, feasibility, and safety of chlorhexidine body cloths, self-administered three times weekly, in preventing SSTI among recruits in military training facilities; and
Evaluate the effectiveness of chlorhexidine body cloths in decreasing rates of Staphylococcus aureus colonization among military recruits

Condition	Intervention
Staphylococcus Aureus Community-Acquired Infections Staphylococcal Skin Infections	Drug: 2% chlorhexidine gluconate (CHG) impregnated cloths Drug: Comfort Bath cloths

Drug Information available for: Chlorhexidine Chlorhexidine digluconate D-Gluconic acid, monosodium salt Gluconic acid Manganese gluconate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Chlorhexidine Impregnated Cloths to Prevent Skin and Soft Tissue Infections in Marine Officer Candidates: A Randomized, Double-Blind, Placebo-Controlled Trial

Further study details as provided by Uniformed Services University of the Health Sciences:

Primary Outcome Measures:

The rate of skin and soft tissue infections among platoons enrolled in OCS [ Time Frame: May - Nov 2007 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The rate of new S. aureus colonization of the nares and axilla among platoons enrolled in OCS. [ Time Frame: May- Nov 2007 ] [ Designated as safety issue: No ]

Enrollment:	1563
Study Start Date:	May 2007
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 2% chlorhexidine gluconate impregnated cloths, self applied three times weekly	Drug: 2% chlorhexidine gluconate (CHG) impregnated cloths self applied three times per week
2: Placebo Comparator Comfort Bath cloths, self applied three times weekly	Drug: Comfort Bath cloths self applied three times weekly

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Enrolled in US Marine Officer Candidates School
Age 18-35 years
Provide documented informed consent and HIPAA authorization

Exclusion Criteria:

Is currently taking oral antibiotics and will continue to take antibiotics during the study (such as antibiotics used to treat acne)
Has a known or suspected allergy or intolerance to chlorhexidine (Hibistat, Hibiclens)
Is currently using certain skin products and is uninterested in stopping use of the products during the study
Pregnant or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475930

Locations

United States, Virginia
Officer Candidates School - Marine Corps Base Quantico
Quantico, Virginia, United States, 22134

Sponsors and Collaborators

Uniformed Services University of the Health Sciences

Investigators

Principal Investigator:

Timothy J Whitman, DO

National Naval Medical Center

More Information

Responsible Party:	USUHS ( IDCRP )
Study ID Numbers:	HU87F7
Study First Received:	May 18, 2007
Last Updated:	April 14, 2008
ClinicalTrials.gov Identifier:	NCT00475930
Health Authority:	United States: Institutional Review Board

Keywords provided by Uniformed Services University of the Health Sciences:

MRSA
Staphylococcus aureus

Study placed in the following topic categories:

Bacterial Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Skin Diseases, Infectious
Chlorhexidine
Soft Tissue Infections

Skin Diseases
Chlorhexidine gluconate
Skin Diseases, Bacterial
Community-Acquired Infections
Staphylococcal Skin Infections

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Infective Agents, Local
Communicable Diseases
Disinfectants

Therapeutic Uses
Infection
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009