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

Staphylococcus Aureus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00475930
• Other study ID #: HU87F7
• Status: Completed
• Phase: N/A
• First received: May 18, 2007
• Last updated: September 1, 2009
• Start date: May 2007
• Est. completion date: November 2007

Study information

• Verified date: September 2009
• Source: Uniformed Services University of the Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1563
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Community-Acquired Infections
• Infection
• Skin Diseases, Infectious
• Soft Tissue Infections
• Staphylococcal Skin Infections
• Staphylococcus Aureus

Intervention

Drug:
• 2% chlorhexidine gluconate (CHG) impregnated cloths
self applied three times per week
• Comfort Bath cloths (placebo cloths)
self applied three times weekly

Locations

Country	Name	City	State
United States	Officer Candidates School - Marine Corps Base Quantico	Quantico	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Uniformed Services University of the Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of skin and soft tissue infections among platoons enrolled in OCS.		May - Nov 2007	No
Secondary	The rate of new S. aureus colonization of the nares and axilla among platoons enrolled in OCS.		May- Nov 2007	No