MRSA 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: February 13, 2013
Last verified: February 2013
  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
Community-associated MRSA Infections
Staphylococcal Skin Infections
Drug: Chlorhexidine gluconate
Other: Standardized training and education

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:
  • Rates of SSTI [ Time Frame: At the end of each 14 week training cycle ] [ Designated as safety issue: No ]
  • Rates of MRSA-associated SSTI [ Time Frame: At the end of each 14 week training cycle ] [ 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 Basic approach
Active Comparator: Group 2 Enhanced standard Other: Standardized training and education
Supplemental SSTI education for trainees and drill sergeants, standardized guidance on SSTI surveillance (e.g., skin inspection) by drill sergeants, will be instructed to take a 10-minute shower with soap and a wash cloth every Sunday while in garrison (in addition to routine showering), and will be issued a personal first aid kit. Education for trainees includes being issued a MRSA pocket card and MRSA SSTI awareness posters in the barracks. Education for the drill sergeants consists of a web-based standardized initial briefing on MRSA SSTI awareness and skin inspection/minor wound care (See Drill Sergeant Briefing). Additionally, drill sergeants will receive periodic email reminders (every training cycle) and twice yearly standardized training on MRSA SSTI awareness and skin inspection. Medical personnel who staff battalion aid stations will be trained in MRSA SSTI awareness and skin inspection/minor wound care.
Active Comparator: Group 3 Chlorhexidine Drug: Chlorhexidine gluconate
Self applied once a week to wash/cover the body (except the face and genitalia). Wash should remain on the skin for approximately three minutes before the final rinse.

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
Last Updated: February 13, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 25, 2014