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

Staphylococcus Aureus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01105767
• Other study ID #: IDCRP-055
• Status: Completed
• Phase: N/A
• Start date: May 2010
• Est. completion date: January 2012

Study information

• Verified date: February 2023
• Source: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30209
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Cellulitis
• Communicable Diseases
• Infections
• MRSA Skin Infections
• Skin Diseases, Infectious
• Soft Tissue Infections
• Staphylococcal Infections
• Staphylococcal Skin Infections
• Staphylococcus Aureus

Intervention

Drug:
• Chlorhexidine gluconate
Self applied chlorhexidine body wash (4% chlorhexidine gluconate, Hibiclens®, M?lnlycke Heath Care, Norcross, Georgia) once a week to wash/cover the body (except the face and genitalia).

Other:
• Supplemental training, education and hygiene
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.

Locations

Country	Name	City	State
United States	Usa Meddac Mach	Columbus	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Henry M. Jackson Foundation for the Advancement of Military Medicine	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Skin and Soft Tissue Infection (SSTI)		At the end of the 20 month study
Primary	Incidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI		At the end of the 20 month study