Clinical trial NCT00475930: Chlorhexidine Impregnated Cloths to Prevent Skin and Soft Tissue Infections in Marine Officer Candidates
Official title: Chlorhexidine Impregnated Cloths to Prevent Skin and Soft Tissue Infections in Marine Officer Candidates: A Randomized, Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Staphylococcus Aureus
Community-Acquired Infections
Staphylococcal Skin Infections
Keywords: MRSA
Staphylococcus aureus
Lead sponsor: Uniformed Services University of the Health Sciences
Sponsor class: FED
First posted: 2007-05-21
Enrollment: 1563
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

The investigators propose a randomized, double blind, placebo controlled trial to:

1. 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
2. Evaluate the effectiveness of chlorhexidine body cloths in decreasing rates of Staphylococcus aureus colonization among military recruits.


Eligibility 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

Primary outcomes:
measure: The rate of skin and soft tissue infections among platoons enrolled in OCS.
timeFrame: May - Nov 2007
Secondary outcomes:
measure: The rate of new S. aureus colonization of the nares and axilla among platoons enrolled in OCS.
timeFrame: May- Nov 2007
Other outcomes:
Locations:
city: Quantico
country: United States
facility: Officer Candidates School - Marine Corps Base Quantico
state: Virginia
Study officials:
affiliation: National Naval Medical Center
name: Timothy J Whitman, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Whitman TJ, Herlihy RK, Schlett CD, Murray PR, Grandits GA, Ganesan A, Brown M, Mancuso JD, Adams WB, Tribble DR. Chlorhexidine-impregnated cloths to prevent skin and soft-tissue infection in Marine recruits: a cluster-randomized, double-blind, controlled effectiveness trial. Infect Control Hosp Epidemiol. 2010 Dec;31(12):1207-15. doi: 10.1086/657136. Epub 2010 Oct 28.