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

Henry M. Jackson Foundation for the Advancement of Military Medicine

Status: Completed

Conditions: Staphylococcal Skin Infections; Staphylococcus Aureus; Community-acquired Infections

Treatments: Drug: 2% chlorhexidine gluconate (CHG) impregnated cloths; Drug: Comfort Bath cloths (placebo cloths)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00475930

HU87F7

Details and patient eligibility

About

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.

Enrollment: 1,563 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,563 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

2% chlorhexidine gluconate impregnated cloths, self applied three times weekly

Treatment:

Drug: 2% chlorhexidine gluconate (CHG) impregnated cloths

2

Placebo Comparator group

Description:

Comfort Bath cloths, self applied three times weekly

Treatment:

Drug: Comfort Bath cloths (placebo cloths)