Evaluating Strategies to Prevent Methicillin-resistant Staphylococcus Aureus Skin and Soft Tissue Infections in Military Trainees



Status:Completed
Conditions:Skin and Soft Tissue Infections, Infectious Disease, Hospital
Therapuetic Areas:Dermatology / Plastic Surgery, Immunology / Infectious Diseases, Other
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:May 2010
End Date:June 2012
Contact:Michael Ellis, MD
Email:Michael.Ellis@usuhs.mil
Phone:301-295-2254

Use our guide to learn which trials are right for you!


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.

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
We found this trial at
1
site
Columbus, Georgia 31905
?
mi
from
Columbus, GA
Click here to add this to my saved trials