Trial Outcomes & Findings for Methicillin-resistant Staphylococcus Aureus (MRSA) Skin and Soft Tissue Infection (SSTI) Prevention in Military Trainees (NCT NCT01105767)
NCT ID: NCT01105767
Last Updated: 2023-02-03
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30209 participants
Primary outcome timeframe
At the end of the 20 month study
Results posted on
2023-02-03
Participant Flow
Participant milestones
| Measure |
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 standard Environmental Protection Agency registered disinfectants.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9315
|
10864
|
10030
|
|
Overall Study
COMPLETED
|
8155
|
9250
|
8846
|
|
Overall Study
NOT COMPLETED
|
1160
|
1614
|
1184
|
Reasons for withdrawal
| Measure |
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 standard Environmental Protection Agency registered disinfectants.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1160
|
1614
|
1184
|
Baseline Characteristics
Methicillin-resistant Staphylococcus Aureus (MRSA) Skin and Soft Tissue Infection (SSTI) Prevention in Military Trainees
Baseline characteristics by cohort
| Measure |
Group 1 Standard
n=303 Participants
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.
|
Group 2 Enhanced Standard
n=439 Participants
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.
|
Group 3 Chlorhexidine
n=461 Participants
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.
|
Total
n=1203 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
20.4 years
STANDARD_DEVIATION 3.1 • n=99 Participants
|
20.3 years
STANDARD_DEVIATION 3.2 • n=107 Participants
|
20.3 years
STANDARD_DEVIATION 2.9 • n=206 Participants
|
20.3 years
STANDARD_DEVIATION 3.0 • n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
303 Participants
n=99 Participants
|
439 Participants
n=107 Participants
|
461 Participants
n=206 Participants
|
1203 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
92 participants
n=99 Participants
|
167 participants
n=107 Participants
|
172 participants
n=206 Participants
|
431 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
13 participants
n=99 Participants
|
24 participants
n=107 Participants
|
18 participants
n=206 Participants
|
55 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black, non-Hispanic
|
7 participants
n=99 Participants
|
7 participants
n=107 Participants
|
4 participants
n=206 Participants
|
18 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other, non-Hispanic
|
5 participants
n=99 Participants
|
8 participants
n=107 Participants
|
5 participants
n=206 Participants
|
18 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
186 participants
n=99 Participants
|
233 participants
n=107 Participants
|
262 participants
n=206 Participants
|
681 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: At the end of the 20 month studyOutcome measures
| Measure |
Group 1 Standard
n=9 Participants
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 (TMC). High-touch common surfaces within the battalion areas were cleaned with standard Environmental Protection Agency-registered disinfectants.
|
Group 2 Enhanced Standard
n=10 Participants
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.
|
Group 3 Chlorhexidine
n=10 Participants
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.
|
|---|---|---|---|
|
Incidence of Skin and Soft Tissue Infection (SSTI)
|
303 participants
|
439 participants
|
461 participants
|
PRIMARY outcome
Timeframe: At the end of the 20 month studyOutcome measures
| Measure |
Group 1 Standard
n=9 Participants
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 (TMC). High-touch common surfaces within the battalion areas were cleaned with standard Environmental Protection Agency-registered disinfectants.
|
Group 2 Enhanced Standard
n=10 Participants
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.
|
Group 3 Chlorhexidine
n=10 Participants
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.
|
|---|---|---|---|
|
Incidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI
|
86 participants
|
135 participants
|
95 participants
|
Adverse Events
Group 1 Standard
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2 Enhanced Standard
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3 Chlorhexidine
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1 Standard
n=9315 participants at risk
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.
|
Group 2 Enhanced Standard
n=10864 participants at risk
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.
|
Group 3 Chlorhexidine
n=10030 participants at risk
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.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis due to soap
|
0.00%
0/9315
|
0.00%
0/10864
|
0.04%
4/10030 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place