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

Not Applicable

Completed

• Conditions: Community-Acquired Infections; Staphylococcus Aureus; Staphylococcal Skin Infections
• Interventions: Drug: 2% chlorhexidine gluconate (CHG) impregnated cloths; Drug: Comfort Bath cloths (placebo cloths)

• Registration Number: NCT00475930
• Lead Sponsor: Uniformed Services University of the Health Sciences

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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-18
• Study First Submitted QC: 2007-05-18
• Study First Posted: 2007-05-21
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-01
• Last Update Posted: 2009-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1563

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	2% chlorhexidine gluconate (CHG) impregnated cloths	2% chlorhexidine gluconate impregnated cloths, self applied three times weekly
2	Comfort Bath cloths (placebo cloths)	Comfort Bath cloths, self applied three times weekly

Primary Outcome Measures

Name	Time	Method
The rate of skin and soft tissue infections among platoons enrolled in OCS.	May - Nov 2007

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Officer Candidates School - Marine Corps Base Quantico; 🇺🇸 Quantico, Virginia, United States