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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dr. Michael Ellis, Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier:
NCT01105767
First received: April 14, 2010
Last updated: November 2, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Staphylococcus Aureus
MRSA Skin Infections
Staphylococcal Skin Infections
Drug: Chlorhexidine gluconate
Other: Supplemental training, education and hygiene

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluating Strategies to Prevent Methicillin-resistant Staphylococcus Aureus Skin and Soft Tissue Infections in Military Trainees

Resource links provided by NLM:


Further study details as provided by Uniformed Services University of the Health Sciences:

Primary Outcome Measures:
  • Incidence of Skin and Soft Tissue Infection (SSTI) [ Time Frame: At the end of the 20 month study ] [ Designated as safety issue: No ]
  • Incidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI [ Time Frame: At the end of the 20 month study ] [ Designated as safety issue: No ]

Enrollment: 30209
Study Start Date: May 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01105767

Locations
United States, Georgia
Usa Meddac Mach
Columbus, Georgia, United States, 31905
Sponsors and Collaborators
Uniformed Services University of the Health Sciences
Investigators
Principal Investigator: Michael Ellis, MD Uniformed Services University of the Health Sciences
  More Information

No publications provided by Uniformed Services University of the Health Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Michael Ellis, Assistant Professor, Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier: NCT01105767     History of Changes
Other Study ID Numbers: IDCRP-055
Study First Received: April 14, 2010
Results First Received: March 6, 2014
Last Updated: November 2, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Uniformed Services University of the Health Sciences:
Staphylococcus aureus
MRSA Skin Infection
Staphylococcal Skin Infections
Chlorhexidine gluconate

Additional relevant MeSH terms:
Communicable Diseases
Infection
Skin Diseases, Infectious
Soft Tissue Infections
Staphylococcal Infections
Staphylococcal Skin Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Skin Diseases
Skin Diseases, Bacterial
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents
Anti-Infective Agents, Local
Dermatologic Agents
Disinfectants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014