Chlorhexidine Impregnated Cloths to Prevent Skin and Soft Tissue Infections in Marine Officer Candidates
|ClinicalTrials.gov Identifier: NCT00475930|
Recruitment Status : Completed
First Posted : May 21, 2007
Last Update Posted : September 2, 2009
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:
- 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
- Evaluate the effectiveness of chlorhexidine body cloths in decreasing rates of Staphylococcus aureus colonization among military recruits.
|Condition or disease||Intervention/treatment||Phase|
|Staphylococcus Aureus Community-Acquired Infections Staphylococcal Skin Infections||Drug: 2% chlorhexidine gluconate (CHG) impregnated cloths Drug: Comfort Bath cloths (placebo cloths)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1563 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Chlorhexidine Impregnated Cloths to Prevent Skin and Soft Tissue Infections in Marine Officer Candidates: A Randomized, Double-Blind, Placebo-Controlled Trial|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||November 2007|
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.
- The rate of skin and soft tissue infections among platoons enrolled in OCS. [ Time Frame: May - Nov 2007 ]
- The rate of new S. aureus colonization of the nares and axilla among platoons enrolled in OCS. [ Time Frame: May- Nov 2007 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00475930
|United States, Virginia|
|Officer Candidates School - Marine Corps Base Quantico|
|Quantico, Virginia, United States, 22134|
|Principal Investigator:||Timothy J Whitman, DO||National Naval Medical Center|