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Methicillin-resistant Staphylococcus Aureus (MRSA) Skin and Soft Tissue Infection (SSTI) Prevention in Military Trainees

Primary Purpose

Staphylococcus Aureus, MRSA Skin Infections, Staphylococcal Skin Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chlorhexidine gluconate
Supplemental training, education and hygiene
Sponsored by
Henry M. Jackson Foundation for the Advancement of Military Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Staphylococcus Aureus focused on measuring Staphylococcus aureus, MRSA Skin Infection, Staphylococcal Skin Infections, Chlorhexidine gluconate

Eligibility Criteria

18 Years - 42 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Usa Meddac Mach

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Group 1 Standard

Group 2 Enhanced Standard

Group 3 Chlorhexidine

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Incidence of Skin and Soft Tissue Infection (SSTI)
Incidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI

Secondary Outcome Measures

Full Information

First Posted
April 14, 2010
Last Updated
February 1, 2023
Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT01105767
Brief Title
Methicillin-resistant Staphylococcus Aureus (MRSA) Skin and Soft Tissue Infection (SSTI) Prevention in Military Trainees
Official Title
Evaluating Strategies to Prevent Methicillin-resistant Staphylococcus Aureus Skin and Soft Tissue Infections in Military Trainees
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcus Aureus, MRSA Skin Infections, Staphylococcal Skin Infections
Keywords
Staphylococcus aureus, MRSA Skin Infection, Staphylococcal Skin Infections, Chlorhexidine gluconate

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30209 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 Standard
Arm Type
No Intervention
Arm Description
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.
Arm Title
Group 2 Enhanced Standard
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 3 Chlorhexidine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine gluconate
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Supplemental training, education and hygiene
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Skin and Soft Tissue Infection (SSTI)
Time Frame
At the end of the 20 month study
Title
Incidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI
Time Frame
At the end of the 20 month study

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Ellis, MD
Organizational Affiliation
Uniformed Services University of the Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Usa Meddac Mach
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31905
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33215698
Citation
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.
Results Reference
derived
PubMed Identifier
27780238
Citation
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.
Results Reference
derived
PubMed Identifier
27387422
Citation
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.
Results Reference
derived
PubMed Identifier
25695181
Citation
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.
Results Reference
derived
PubMed Identifier
25421482
Citation
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.
Results Reference
derived
PubMed Identifier
25203178
Citation
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.
Results Reference
derived
PubMed Identifier
24633684
Citation
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.
Results Reference
derived

Learn more about this trial

Methicillin-resistant Staphylococcus Aureus (MRSA) Skin and Soft Tissue Infection (SSTI) Prevention in Military Trainees

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