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

Primary Purpose

Staphylococcus Aureus, Community-Acquired Infections, Staphylococcal Skin Infections

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

2% chlorhexidine gluconate (CHG) impregnated cloths

Comfort Bath cloths (placebo cloths)

About this trial

This is an interventional prevention trial for Staphylococcus Aureus focused on measuring MRSA, Staphylococcus aureus

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Officer Candidates School - Marine Corps Base Quantico

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

2% chlorhexidine gluconate impregnated cloths, self applied three times weekly

Comfort Bath cloths, self applied three times weekly

Outcomes

Primary Outcome Measures

The rate of skin and soft tissue infections among platoons enrolled in OCS.

Secondary Outcome Measures

The rate of new S. aureus colonization of the nares and axilla among platoons enrolled in OCS.

Full Information

NCT ID

NCT00475930

First Posted

May 18, 2007

Last Updated

September 1, 2009

Sponsor

Uniformed Services University of the Health Sciences

1. Study Identification

Unique Protocol Identification Number

NCT00475930

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

November 2007 (Actual)

Study Completion Date

November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Uniformed Services University of the Health Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Staphylococcus Aureus, Community-Acquired Infections, Staphylococcal Skin Infections

Keywords

MRSA, Staphylococcus aureus

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1563 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

2% chlorhexidine gluconate impregnated cloths, self applied three times weekly

Arm Title

Arm Type

Placebo Comparator

Arm Description

Comfort Bath cloths, self applied three times weekly

Intervention Type

Drug

Intervention Name(s)

2% chlorhexidine gluconate (CHG) impregnated cloths

Other Intervention Name(s)

Sage Products Inc.

Intervention Description

self applied three times per week

Intervention Type

Drug

Intervention Name(s)

Comfort Bath cloths (placebo cloths)

Other Intervention Name(s)

Sage Products Inc.

Intervention Description

self applied three times weekly

Primary Outcome Measure Information:

Title

The rate of skin and soft tissue infections among platoons enrolled in OCS.

Time Frame

May - Nov 2007

Secondary Outcome Measure Information:

Title

The rate of new S. aureus colonization of the nares and axilla among platoons enrolled in OCS.

Time Frame

May- Nov 2007

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Timothy J Whitman, DO

Organizational Affiliation

National Naval Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Officer Candidates School - Marine Corps Base Quantico

City

Quantico

State/Province

Virginia

ZIP/Postal Code

22134

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21028984

Citation

Whitman TJ, Herlihy RK, Schlett CD, Murray PR, Grandits GA, Ganesan A, Brown M, Mancuso JD, Adams WB, Tribble DR. Chlorhexidine-impregnated cloths to prevent skin and soft-tissue infection in Marine recruits: a cluster-randomized, double-blind, controlled effectiveness trial. Infect Control Hosp Epidemiol. 2010 Dec;31(12):1207-15. doi: 10.1086/657136. Epub 2010 Oct 28.

Results Reference

derived

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

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