Chlorhexidine Impregnated Cloths to Prevent Skin and Soft Tissue Infections in Marine Officer Candidates

Study Overview
=================
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: 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.

Official Title
-----------------
Chlorhexidine Impregnated Cloths to Prevent Skin and Soft Tissue Infections in Marine Officer Candidates: A Randomized, Double-Blind, Placebo-Controlled Trial

Conditions
-----------------
Staphylococcus Aureus, Community-Acquired Infections, Staphylococcal Skin Infections

Intervention / Treatment
-----------------
* Drug: 2% chlorhexidine gluconate (CHG) impregnated cloths
* Drug: Comfort Bath cloths (placebo cloths)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>2% chlorhexidine gluconate impregnated cloths, self applied three times weekly | Drug: 2% chlorhexidine gluconate (CHG) impregnated cloths<br>* self applied three times per week<br>* Other names: Sage Products Inc.;|
| Placebo Comparator: 2<br>Comfort Bath cloths, self applied three times weekly | Drug: Comfort Bath cloths (placebo cloths)<br>* self applied three times weekly<br>* Other names: Sage Products Inc.;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of skin and soft tissue infections among platoons enrolled in OCS. |  | May - Nov 2007 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of new S. aureus colonization of the nares and axilla among platoons enrolled in OCS. |  | May- Nov 2007 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRSA, Staphylococcus aureus