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

September 1, 2009 updated by: Uniformed Services University of the Health Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1563

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Quantico, Virginia, United States, 22134
        • Officer Candidates School - Marine Corps Base Quantico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uniformed Services University of the Health Sciences

Investigators

  • Principal Investigator: Timothy J Whitman, DO, National Naval Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (ACTUAL)

November 1, 2007

Study Completion (ACTUAL)

November 1, 2007

Study Registration Dates

First Submitted

May 18, 2007

First Submitted That Met QC Criteria

May 18, 2007

First Posted (ESTIMATE)

May 21, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

September 2, 2009

Last Update Submitted That Met QC Criteria

September 1, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HU87F7

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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