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

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ClinicalTrials.gov Identifier: NCT01105767
Recruitment Status : Completed
First Posted : April 16, 2010
Results First Posted : November 4, 2014
Last Update Posted : November 4, 2014
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Dr. Michael Ellis, Uniformed Services University of the Health Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Staphylococcus Aureus
MRSA Skin Infections
Staphylococcal Skin Infections
Interventions Drug: Chlorhexidine gluconate
Other: Supplemental training, education and hygiene
Enrollment 30209

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1 Standard Group 2 Enhanced Standard Group 3 Chlorhexidine
Hide Arm/Group 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 standard Environmental Protection Agency registered disinfectants. 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. 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.
Period Title: Overall Study
Started 9315 10864 10030
Completed 8155 9250 8846
Not Completed 1160 1614 1184
Reason Not Completed
Lost to Follow-up             1160             1614             1184
Arm/Group Title Group 1 Standard Group 2 Enhanced Standard Group 3 Chlorhexidine Total
Hide Arm/Group 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 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. 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 of all reporting groups
Overall Number of Baseline Participants 303 439 461 1203
Hide Baseline Analysis Population Description
Participants that developed SSTI.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 303 participants 439 participants 461 participants 1203 participants
20.4  (3.1) 20.3  (3.2) 20.3  (2.9) 20.3  (3.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 303 participants 439 participants 461 participants 1203 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
303
 100.0%
439
 100.0%
461
 100.0%
1203
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 303 participants 439 participants 461 participants 1203 participants
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
1.Primary Outcome
Title Incidence of Skin and Soft Tissue Infection (SSTI)
Hide Description [Not Specified]
Time Frame At the end of the 20 month study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Standard Group 2 Enhanced Standard Group 3 Chlorhexidine
Hide Arm/Group 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 (TMC). 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 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.
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 Number of Participants Analyzed 9315 10864 10030
Measure Type: Number
Unit of Measure: participants
303 439 461
2.Primary Outcome
Title Incidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI
Hide Description [Not Specified]
Time Frame At the end of the 20 month study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Standard Group 2 Enhanced Standard Group 3 Chlorhexidine
Hide Arm/Group 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 (TMC). 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 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.
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 Number of Participants Analyzed 9315 10864 10030
Measure Type: Number
Unit of Measure: participants
86 135 95
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 Standard Group 2 Enhanced Standard Group 3 Chlorhexidine
Hide Arm/Group 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 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. 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.
All-Cause Mortality
Group 1 Standard Group 2 Enhanced Standard Group 3 Chlorhexidine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 Standard Group 2 Enhanced Standard Group 3 Chlorhexidine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9,315      0/10,864      0/10,030    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1 Standard Group 2 Enhanced Standard Group 3 Chlorhexidine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9,315      0/10,864      4/10,030    
Skin and subcutaneous tissue disorders       
Dermatitis due to soap   0/9315 (0.00%)  0 0/10864 (0.00%)  0 4/10030 (0.04%)  4
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: LTC Michael Ellis
Organization: USUHS
Phone: 301-295-2254
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Michael Ellis, Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier: NCT01105767     History of Changes
Other Study ID Numbers: IDCRP-055
First Submitted: April 14, 2010
First Posted: April 16, 2010
Results First Submitted: March 6, 2014
Results First Posted: November 4, 2014
Last Update Posted: November 4, 2014