An interventional study of Chlorhexidine gluconate and Supplemental training, education and hygiene in Staphylococcus Aureus, MRSA Skin Infections and Staphylococcal Skin Infections, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine. Completed at 1 site in United States. Open to male participants aged 18 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-03.
Sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine · Not applicable, Interventional, and Prevention
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.
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.
30 studies on the registry are indexed under Staphylococcal Skin Infections; none are open to participants now.
This study's enrollment of 30,209 is above the median of 227 across 28 interventional studies indexed under Staphylococcal Skin Infections.
Browse Staphylococcal Skin Infections studies →Henry M. Jackson Foundation for the Advancement of Military Medicine is the lead sponsor of 86 studies on the registry; 18 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
Compared within Staphylococcal Skin Infections, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Staphylococcal Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Supplemental training, education and hygiene
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.
Drug: Chlorhexidine gluconate · Other: Supplemental training, education and hygiene
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.
Incidence of Skin and Soft Tissue Infection (SSTI)
Time frame: At the end of the 20 month study
Incidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI
Time frame: At the end of the 20 month study
| Milestone | Group 1 Standard | Group 2 Enhanced Standard | Group 3 Chlorhexidine |
|---|---|---|---|
| Started | 9315 | 10864 | 10030 |
| Completed | 8155 | 9250 | 8846 |
| Not completed | 1160 | 1614 | 1184 |
| Withdrew: Lost to follow-up | 1160 | 1614 | 1184 |
| participants | Group 1 Standard | Group 2 Enhanced Standard | Group 3 Chlorhexidine |
|---|---|---|---|
| Incidence of Skin and Soft Tissue Infection (SSTI) | 303 | 439 | 461 |
| participants | Group 1 Standard | Group 2 Enhanced Standard | Group 3 Chlorhexidine |
|---|---|---|---|
| Incidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI | 86 | 135 | 95 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 Standard | — | 0/9,315 (0%) | 0/9,315 (0%) |
| Group 2 Enhanced Standard | — | 0/10,864 (0%) | 0/10,864 (0%) |
| Group 3 Chlorhexidine | — | 0/10,030 (0%) | 4/10,030 (0%) |
| Event | Group 1 Standard | Group 2 Enhanced Standard | Group 3 Chlorhexidine |
|---|---|---|---|
| Dermatitis due to soapSkin and subcutaneous tissue disorders | 0/9315 | 0/10864 | 4/10030 |
Participants that developed SSTI.
| Age, Continuous(years) | Group 1 Standard | Group 2 Enhanced Standard | Group 3 Chlorhexidine | Total |
|---|---|---|---|---|
| Mean | 20.4 ± 3.1 | 20.3 ± 3.2 | 20.3 ± 2.9 | 20.3 ± 3.0 |
| Sex: Female, Male(Participants) | Group 1 Standard | Group 2 Enhanced Standard | Group 3 Chlorhexidine | Total |
|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 |
| Male | 303 | 439 | 461 | 1203 |
| Race/Ethnicity, Customized(participants) | Group 1 Standard | Group 2 Enhanced Standard | Group 3 Chlorhexidine | Total |
|---|---|---|---|---|
| White, non-Hispanic | 92 | 167 | 172 | 431 |
| Hispanic | 13 | 24 | 18 | 55 |
| Black, non-Hispanic | 7 | 7 | 4 | 18 |
| Other, non-Hispanic | 5 | 8 | 5 | 18 |
| Unknown | 186 | 233 | 262 | 681 |
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Chlorhexidine gluconate
Staphylococcal Skin Infections →
Henry M. Jackson Foundation for the Advancement of Military Medicine