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
1 other identifier
interventional
30,209
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2010
CompletedFirst Posted
Study publicly available on registry
April 16, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
November 4, 2014
CompletedFebruary 3, 2023
February 1, 2023
1.7 years
April 14, 2010
March 6, 2014
February 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of Skin and Soft Tissue Infection (SSTI)
At the end of the 20 month study
Incidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI
At the end of the 20 month study
Study Arms (3)
Group 1 Standard
NO INTERVENTIONTrainees 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.
Group 2 Enhanced Standard
ACTIVE COMPARATORTrainees 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.
Group 3 Chlorhexidine
ACTIVE COMPARATORTrainees 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.
Interventions
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).
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.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Usa Meddac Mach
Columbus, Georgia, 31905, United States
Related Publications (8)
Jefferson T, Dooley L, Ferroni E, Al-Ansary LA, van Driel ML, Bawazeer GA, Jones MA, Hoffmann TC, Clark J, Beller EM, Glasziou PP, Conly JM. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database Syst Rev. 2023 Jan 30;1(1):CD006207. doi: 10.1002/14651858.CD006207.pub6.
PMID: 36715243DERIVEDJefferson 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.
PMID: 33215698DERIVEDJohnson 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.
PMID: 27780238DERIVEDMillar 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.
PMID: 27387422DERIVEDD'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.
PMID: 25695181DERIVEDMillar 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.
PMID: 25421482DERIVEDEllis 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.
PMID: 25203178DERIVEDEllis 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.
PMID: 24633684DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- LTC Michael Ellis
- Organization
- USUHS
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Ellis, MD
Uniformed Services University of the Health Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2010
First Posted
April 16, 2010
Study Start
May 1, 2010
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
February 3, 2023
Results First Posted
November 4, 2014
Record last verified: 2023-02