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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01105767
Enrollment
30209
Registered
2010-04-16
Start date
2010-05-31
Completion date
2012-01-31
Last updated
2023-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MRSA Skin Infections, Staphylococcal Skin Infections, Staphylococcus Aureus

Keywords

Staphylococcus aureus, MRSA Skin Infection, Staphylococcal Skin Infections, Chlorhexidine gluconate

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.

Interventions

DRUGChlorhexidine gluconate

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).

OTHERSupplemental 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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 42 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Incidence of Skin and Soft Tissue Infection (SSTI)At the end of the 20 month study
Incidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTIAt the end of the 20 month study

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
303
Group 2 Enhanced Standard
Trainees received the components of the Standard group and 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.
439
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.
461
Total1,203

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyLost to Follow-up1,1601,6141,184

Baseline characteristics

CharacteristicGroup 1 StandardGroup 2 Enhanced StandardGroup 3 ChlorhexidineTotal
Age, Continuous20.4 years
STANDARD_DEVIATION 3.1
20.3 years
STANDARD_DEVIATION 3.2
20.3 years
STANDARD_DEVIATION 2.9
20.3 years
STANDARD_DEVIATION 3
Race/Ethnicity, Customized
Black, non-Hispanic
7 participants7 participants4 participants18 participants
Race/Ethnicity, Customized
Hispanic
13 participants24 participants18 participants55 participants
Race/Ethnicity, Customized
Other, non-Hispanic
5 participants8 participants5 participants18 participants
Race/Ethnicity, Customized
Unknown
186 participants233 participants262 participants681 participants
Race/Ethnicity, Customized
White, non-Hispanic
92 participants167 participants172 participants431 participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
Male
303 Participants439 Participants461 Participants1203 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 9,3150 / 10,8644 / 10,030
serious
Total, serious adverse events
0 / 9,3150 / 10,8640 / 10,030

Outcome results

Primary

Incidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI

Time frame: At the end of the 20 month study

ArmMeasureValue (NUMBER)
Group 1 StandardIncidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI86 participants
Group 2 Enhanced StandardIncidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI135 participants
Group 3 ChlorhexidineIncidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI95 participants
Primary

Incidence of Skin and Soft Tissue Infection (SSTI)

Time frame: At the end of the 20 month study

ArmMeasureValue (NUMBER)
Group 1 StandardIncidence of Skin and Soft Tissue Infection (SSTI)303 participants
Group 2 Enhanced StandardIncidence of Skin and Soft Tissue Infection (SSTI)439 participants
Group 3 ChlorhexidineIncidence of Skin and Soft Tissue Infection (SSTI)461 participants

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026