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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00475930
Enrollment
1563
Registered
2007-05-21
Start date
2007-05-31
Completion date
2007-11-30
Last updated
2025-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community-acquired Infections, Staphylococcal Skin Infections, Staphylococcus Aureus

Keywords

MRSA, Staphylococcus aureus

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.

Interventions

DRUG2% chlorhexidine gluconate (CHG) impregnated cloths

self applied three times per week

DRUGComfort Bath cloths (placebo cloths)

self applied three times weekly

Sponsors

Uniformed Services University of the Health Sciences
CollaboratorFED
Henry M. Jackson Foundation for the Advancement of Military Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
The rate of skin and soft tissue infections among platoons enrolled in OCS.May - Nov 2007

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026