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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Group 1 Standard   Group 2 Enhanced Standard   Group 3 Chlorhexidine
STARTED   9315   10864   10030 
COMPLETED   8155   9250   8846 
NOT COMPLETED   1160   1614   1184 
Lost to Follow-up                1160                1614                1184 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants that developed SSTI.

Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
   Group 1 Standard   Group 2 Enhanced Standard   Group 3 Chlorhexidine   Total 
Overall Participants Analyzed 
[Units: Participants]
 303   439   461   1203 
Age 
[Units: Years]
Mean (Standard Deviation)
 20.4  (3.1)   20.3  (3.2)   20.3  (2.9)   20.3  (3.0) 
Gender 
[Units: Participants]
       
Female   0   0   0   0 
Male   303   439   461   1203 
Race/Ethnicity, Customized 
[Units: 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 


  Outcome Measures

1.  Primary:   Incidence of Skin and Soft Tissue Infection (SSTI)   [ Time Frame: At the end of the 20 month study ]

2.  Primary:   Incidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI   [ Time Frame: At the end of the 20 month study ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: Michael.Ellis@usuhs.edu


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