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

NCT00475930 | Completed DMC

• 1 other identifier: HU87F7
• Study Type: interventional
• Target: 1,563
• Locations: 1 country
• Sites: 1

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:

1. 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. 2.Evaluate the effectiveness of chlorhexidine body cloths in decreasing rates of Staphylococcus aureus colonization among military recruits.

Conditions

Staphylococcus Aureus; Community-acquired Infections; Staphylococcal Skin Infections

Keywords

MRSA; Staphylococcus aureus

Outcome Measures

Primary Outcomes (1)

• The rate of skin and soft tissue infections among platoons enrolled in OCS.

  May - Nov 2007

Secondary Outcomes (1)

• The rate of new S. aureus colonization of the nares and axilla among platoons enrolled in OCS.

  May- Nov 2007

Study Arms (2)

1

EXPERIMENTAL

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

Drug: 2% chlorhexidine gluconate (CHG) impregnated cloths

2

PLACEBO COMPARATOR

Comfort Bath cloths, self applied three times weekly

Drug: Comfort Bath cloths (placebo cloths)

Interventions

2% chlorhexidine gluconate (CHG) impregnated cloths DRUG

self applied three times per week

Also known as: Sage Products Inc.

1

Comfort Bath cloths (placebo cloths) DRUG

self applied three times weekly

Also known as: Sage Products Inc.

2

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Enrolled in US Marine Officer Candidates School
• Age 18-35 years
• Provide documented informed consent and HIPAA authorization

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Uniformed Services University of the Health Sciences: collaborator

Study Sites (1)

Officer Candidates School - Marine Corps Base Quantico

Quantico, Virginia, 22134, United States

Location

Related Publications (1)

• Whitman TJ, Herlihy RK, Schlett CD, Murray PR, Grandits GA, Ganesan A, Brown M, Mancuso JD, Adams WB, Tribble DR. Chlorhexidine-impregnated cloths to prevent skin and soft-tissue infection in Marine recruits: a cluster-randomized, double-blind, controlled effectiveness trial. Infect Control Hosp Epidemiol. 2010 Dec;31(12):1207-15. doi: 10.1086/657136. Epub 2010 Oct 28.

  PMID: 21028984 DERIVED

MeSH Terms

Conditions

Staphylococcal Infections; Community-Acquired Infections; Staphylococcal Skin Infections

Interventions

chlorhexidine gluconate; Chromogranins

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nerve Tissue Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors

Study Officials

• Timothy J Whitman, DO

  National Naval Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2007
• First Posted: May 21, 2007
• Study Start: May 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: July 17, 2025

Record last verified: 2025-07

Locations

US (1)