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

This study has been completed.
Sponsor:
Information provided by:
Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier:
NCT00475930
First received: May 18, 2007
Last updated: September 1, 2009
Last verified: September 2009
  Purpose

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.

Condition Intervention
Staphylococcus Aureus
Community-Acquired Infections
Staphylococcal Skin Infections
Drug: 2% chlorhexidine gluconate (CHG) impregnated cloths
Drug: Comfort Bath cloths (placebo cloths)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Uniformed Services University of the Health Sciences:

Primary Outcome Measures:
  • The rate of skin and soft tissue infections among platoons enrolled in OCS. [ Time Frame: May - Nov 2007 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The rate of new S. aureus colonization of the nares and axilla among platoons enrolled in OCS. [ Time Frame: May- Nov 2007 ] [ Designated as safety issue: No ]

Enrollment: 1563
Study Start Date: May 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Sage Products Inc.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475930

Locations
United States, Virginia
Officer Candidates School - Marine Corps Base Quantico
Quantico, Virginia, United States, 22134
Sponsors and Collaborators
Uniformed Services University of the Health Sciences
Investigators
Principal Investigator: Timothy J Whitman, DO National Naval Medical Center
  More Information

No publications provided by Uniformed Services University of the Health Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: IDCRP, USUHS
ClinicalTrials.gov Identifier: NCT00475930     History of Changes
Other Study ID Numbers: HU87F7
Study First Received: May 18, 2007
Last Updated: September 1, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Uniformed Services University of the Health Sciences:
MRSA
Staphylococcus aureus

Additional relevant MeSH terms:
Communicable Diseases
Community-Acquired Infections
Infection
Skin Diseases, Infectious
Soft Tissue Infections
Staphylococcal Skin Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Skin Diseases
Skin Diseases, Bacterial
Staphylococcal Infections
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents
Anti-Infective Agents, Local
Dermatologic Agents
Disinfectants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014