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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1563 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2007-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Staphylococcus Aureus Community-acquired Infections Staphylococcal Skin Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

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

Group Type EXPERIMENTAL

2% chlorhexidine gluconate (CHG) impregnated cloths

Intervention Type DRUG

self applied three times per week

2

Comfort Bath cloths, self applied three times weekly

Group Type PLACEBO_COMPARATOR

Comfort Bath cloths (placebo cloths)

Intervention Type DRUG

self applied three times weekly

Interventions

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2% chlorhexidine gluconate (CHG) impregnated cloths

self applied three times per week

Intervention Type DRUG

Comfort Bath cloths (placebo cloths)

self applied three times weekly

Intervention Type DRUG

Other Intervention Names

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Sage Products Inc. Sage Products Inc.

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes