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Methicillin-resistant Staphylococcus Aureus (MRSA) Skin and Soft Tissue Infection (SSTI) Prevention in Military Trainees

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ClinicalTrials.gov Identifier: NCT01105767
Recruitment Status : Completed
First Posted : April 16, 2010
Results First Posted : November 4, 2014
Last Update Posted : November 4, 2014
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Dr. Michael Ellis, Uniformed Services University of the Health Sciences

April 14, 2010
April 16, 2010
March 6, 2014
November 4, 2014
November 4, 2014
May 2010
January 2012   (Final data collection date for primary outcome measure)
  • Incidence of Skin and Soft Tissue Infection (SSTI) [ Time Frame: At the end of the 20 month study ]
  • Incidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI [ Time Frame: At the end of the 20 month study ]
  • Rates of SSTI [ Time Frame: At the end of each 14 week training cycle ]
  • Rates of MRSA-associated SSTI [ Time Frame: At the end of each 14 week training cycle ]
Complete list of historical versions of study NCT01105767 on ClinicalTrials.gov Archive Site
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Methicillin-resistant Staphylococcus Aureus (MRSA) Skin and Soft Tissue Infection (SSTI) Prevention in Military Trainees
Evaluating Strategies to Prevent Methicillin-resistant Staphylococcus Aureus Skin and Soft Tissue Infections in Military Trainees
This cluster-randomized prospective study will evaluate the effect of hygiene-based intervention strategies on the incidence of overall SSTI and MRSA-associated SSTI among military trainees. The proposed interventions used singly or in combination include standardized training and education, and weekly chlorhexidine showers.

MRSA SSTIs have become endemic in congregate community settings where there is frequent close person-to-person contact, such as athletic teams, correctional facilities, and military training facilities. These infections interfere with the mission of training soldiers as they impair soldiers' ability to participate in required activities and successfully complete a training program. Hygiene-based prevention programs (e.g., hand washing, environmental disinfection, and community-based education) appear to be effective in stemming outbreaks of MRSA SSTIs and need to by systematical evaluated.

This cluster-randomized prospective study will evaluate the effect of hygiene-based intervention strategies on the incidence of overall SSTI and MRSA-associated SSTI among military trainees. The study population will be drawn from six training battalions, each consisting of an average of six companies. Each company is composed of four platoons consisting of approximately 50 trainees. Training battalions are the unit of randomization in this study and sub-clusters (platoons within companies) within each battalion will receive the same hygiene-based intervention assigned to that battalion at study start. During the proposed 20-month evaluation period, five cycles of platoons (approximately 14 weeks per cycle) will enter and exit training activities. In total, the study population will be comprised of approximately 36,000 trainees observed over a 20-month period. Each of the six battalions will receive an in-processing preventive medicine briefing augmented with MRSA prevention information based on U.S. Army Center for Health Promotion and Preventive Medicine (USACHPPM) and Centers for Disease Control and Prevention (CDC) recommendations. Additionally, trainees who seek medical care for a SSTI will receive standardized care at a SSTI clinic applying uniform practice guidance. Four of the battalions will also receive supplemental SSTI education for trainees and drill sergeants, including standardized guidance on SSTI surveillance (e.g., skin inspection) for drill sergeants; trainees will be instructed to take a 10 minute shower with soap every Sunday while in garrison; and will be issued a personal first aid kit. Two of these four battalions will be offered chlorhexidine antiseptic body wash to use during the Sunday shower. Endpoints of the evaluation (i.e., incident SSTIs among military trainees) will be captured through clinical record review at the completion of training.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Staphylococcus Aureus
  • MRSA Skin Infections
  • Staphylococcal Skin Infections
  • Drug: Chlorhexidine gluconate
    Self applied chlorhexidine body wash (4% chlorhexidine gluconate, Hibiclens®, Mӧlnlycke Heath Care, Norcross, Georgia) once a week to wash/cover the body (except the face and genitalia).
  • Other: Supplemental training, education and hygiene
    Supplemental SSTI education for trainees and drill sergeants included pocket cards and posters. Drill sergeants received briefings on SSTI and skin inspection/minor wound care. Trainees were instructed to take an additional 10-minute shower with soap and a wash cloth every week. They were also issued a first aid kit.
  • No Intervention: Group 1 Standard
    Trainees received a preventive medicine briefing augmented with SSTI and MRSA SSTI prevention information and personal hygiene instructions. Trainees seeking medical care for an SSTI received standardized SSTI care (e.g., antimicrobial therapy, wound management, patient education) at the Troop Medical Clinic. High-touch common surfaces within the battalion areas were cleaned with standard Environmental Protection Agency-registered disinfectants.
  • Active Comparator: Group 2 Enhanced Standard
    Trainees received the components of the Standard group as well as supplemental training, education and hygiene. They were instructed to take an additional 10-minute shower with soap and a wash cloth every week. They were also issued a first aid kit. Supplemental SSTI education for trainees and drill sergeants was also provided (e.g., pocket cards, posters). Drill sergeants received briefings on SSTI and skin inspection/minor wound care.
    Intervention: Other: Supplemental training, education and hygiene
  • Active Comparator: Group 3 Chlorhexidine
    Trainees received the components of the Standard and Enhanced Standard groups and were offered chlorhexidine body wash (4% chlorhexidine gluconate, Hibiclens®, Mӧlnlycke Heath Care, Norcross, Georgia) to use with a wash cloth after using their personal soap for the additional once-weekly shower. Trainees were provided with verbal and written/graphic instructions for use.
    Interventions:
    • Drug: Chlorhexidine gluconate
    • Other: Supplemental training, education and hygiene

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30209
36000
January 2012
January 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Trainees assigned to one of the six selected training battalions
  • Trainees who present with an SSTI at the clinic or the hospital
  • Provide informed consent

Exclusion Criteria:

  • Fails to meet inclusion criteria
Sexes Eligible for Study: Male
18 Years to 42 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01105767
IDCRP-055
No
Not Provided
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Dr. Michael Ellis, Uniformed Services University of the Health Sciences
Uniformed Services University of the Health Sciences
Centers for Disease Control and Prevention
Principal Investigator: Michael Ellis, MD Uniformed Services University of the Health Sciences
Uniformed Services University of the Health Sciences
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP