- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01105767
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
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Georgia
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Columbus, Georgia, United States, 31905
- Usa Meddac Mach
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
|
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.
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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.
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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of Skin and Soft Tissue Infection (SSTI)
Time Frame: At the end of the 20 month study
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At the end of the 20 month study
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Incidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI
Time Frame: At the end of the 20 month study
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At the end of the 20 month study
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michael Ellis, MD, Uniformed Services University of the Health Sciences
Publications and helpful links
General Publications
- Jefferson T, Del Mar CB, Dooley L, Ferroni E, Al-Ansary LA, Bawazeer GA, van Driel ML, Jones MA, Thorning S, Beller EM, Clark J, Hoffmann TC, Glasziou PP, Conly JM. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database Syst Rev. 2020 Nov 20;11(11):CD006207. doi: 10.1002/14651858.CD006207.pub5.
- Johnson RC, Ellis MW, Schlett CD, Millar EV, LaBreck PT, Mor D, Elassal EM, Lanier JB, Redden CL, Cui T, Teneza-Mora N, Bishop DK, Hall ER, Bishop-Lilly KA, Merrell DS. Bacterial Etiology and Risk Factors Associated with Cellulitis and Purulent Skin Abscesses in Military Trainees. PLoS One. 2016 Oct 25;11(10):e0165491. doi: 10.1371/journal.pone.0165491. eCollection 2016.
- Millar EV, Schlett CD, Law NN, Chen WJ, D'Onofrio MJ, Bennett JW, Tribble DR, Ellis MW. Reduction in Acute Respiratory Infection Among Military Trainees: Secondary Effects of a Hygiene-Based Cluster-Randomized Trial for Skin and Soft-Tissue Infection Prevention. Infect Control Hosp Epidemiol. 2016 Sep;37(9):1118-20. doi: 10.1017/ice.2016.154. Epub 2016 Jul 8. No abstract available.
- D'Onofrio MJ, Schlett CD, Millar EV, Cui T, Lanier JB, Law NN, Tribble DR, Ellis MW. Reduction in acute gastroenteritis among military trainees: secondary effects of a hygiene-based cluster-randomized trial for skin and soft tissue infection prevention. Infect Control Hosp Epidemiol. 2015 Mar;36(3):358-60. doi: 10.1017/ice.2014.65.
- Millar EV, Chen WJ, Schlett CD, Cui T, Crawford KB, Lanier JB, Tribble DR, Ellis MW. Frequent use of chlorhexidine-based body wash associated with a reduction in methicillin-resistant Staphylococcus aureus nasal colonization among military trainees. Antimicrob Agents Chemother. 2015 Feb;59(2):943-9. doi: 10.1128/AAC.03993-14. Epub 2014 Nov 24.
- Ellis MW, Schlett CD, Millar EV, Crawford KB, Cui T, Lanier JB, Tribble DR. Prevalence of nasal colonization and strain concordance in patients with community-associated Staphylococcus aureus skin and soft-tissue infections. Infect Control Hosp Epidemiol. 2014 Oct;35(10):1251-6. doi: 10.1086/678060. Epub 2014 Aug 19.
- Ellis MW, Schlett CD, Millar EV, Wilkins KJ, Crawford KB, Morrison-Rodriguez SM, Pacha LA, Gorwitz RJ, Lanier JB, Tribble DR. Hygiene strategies to prevent methicillin-resistant Staphylococcus aureus skin and soft tissue infections: a cluster-randomized controlled trial among high-risk military trainees. Clin Infect Dis. 2014 Jun;58(11):1540-8. doi: 10.1093/cid/ciu166. Epub 2014 Mar 14.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Skin Diseases
- Inflammation
- Disease Attributes
- Connective Tissue Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Suppuration
- Skin Diseases, Bacterial
- Infections
- Communicable Diseases
- Cellulitis
- Skin Diseases, Infectious
- Staphylococcal Skin Infections
- Soft Tissue Infections
- Staphylococcal Infections
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Dermatologic Agents
- Disinfectants
- Chlorhexidine
- Chlorhexidine gluconate
Other Study ID Numbers
- IDCRP-055
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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