MRSA SSTI Prevention in Military Trainees
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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 |
- 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 |
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| United States, Georgia | |
| Usa Meddac Mach | |
| Columbus, Georgia, United States, 31905 | |
| Principal Investigator: | Michael Ellis, MD | Uniformed Services University of the Health Sciences |
More Information
No publications provided
| 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 Staphylococcal Infections Soft Tissue 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 May 16, 2013