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

Sponsor

Uniformed Services University of the Health Sciences (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00475930

Collaborator

(none)

1,563

Enrollment

Location

Arms

Duration (Months)

258.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Staphylococcus Aureus Community-Acquired Infections Staphylococcal Skin Infections	Drug: 2% chlorhexidine gluconate (CHG) impregnated cloths Drug: Comfort Bath cloths (placebo cloths)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

1563 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

Nov 1, 2007

Actual Study Completion Date :

Nov 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 2% chlorhexidine gluconate impregnated cloths, self applied three times weekly	Drug: 2% chlorhexidine gluconate (CHG) impregnated cloths self applied three times per week Other Names: Sage Products Inc.
Placebo Comparator: 2 Comfort Bath cloths, self applied three times weekly	Drug: Comfort Bath cloths (placebo cloths) self applied three times weekly Other Names: Sage Products Inc.

Arm

Intervention/Treatment

Experimental: 1

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

Drug: 2% chlorhexidine gluconate (CHG) impregnated cloths

self applied three times per week

Other Names:

Sage Products Inc.

Placebo Comparator: 2

Comfort Bath cloths, self applied three times weekly

Drug: Comfort Bath cloths (placebo cloths)

self applied three times weekly

Other Names:

Sage Products Inc.

Outcome Measures

Primary Outcome Measures

The rate of skin and soft tissue infections among platoons enrolled in OCS. [May - Nov 2007]

Secondary Outcome Measures

The rate of new S. aureus colonization of the nares and axilla among platoons enrolled in OCS. [May- Nov 2007]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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