Clinical trial NCT00513799
Conditions: Abscesses Furunculosis Staphylococcus Aureus Staphylococcal Skin Infections
Sponsor: Washington University School of Medicine
Start date: 2007-03-01; Completion date: 2010-12-01
Enrollment: 300 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the natural history of community-associated Staphylococcus aureus infections in both adult and pediatric patients by monitoring the rate of recurrent infections in those colonized with S. aureus.

In addition, this study will evaluate the efficiency of commonly prescribed decolonization measures in patients presenting with S. aureus skin and soft tissue infections.

Detailed description:
Infections with community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) range in severity from superficial skin abscesses to invasive soft tissue infections like cellulitis and pyomyositis. There has been a large increase in the number of patients presenting to our institution with CA-MRSA infections. Colonization with S. aureus (SA) may be linked to the development of infection but data on this phenomenon are limited. The recurrence rate for CA-MRSA soft tissue infections is unknown. A variety of decolonization strategies have been used for infection prophylaxis with varying results, primarily in patients undergoing hemodialysis or surgery. This study seeks to determine the recurrence rate of soft tissue infections among patients with CA-MRSA infections and to determine a reasonable and efficacious decolonization strategy to eradicate CA-MRSA from previously infected patients.

The proposed methods for decolonization will be tested in a randomized controlled trial with four intervention arms. The intervention arms are: (1) intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group"), (2) application of mupirocin in the nasal mucosa alone, (3) a combination of nasal application of mupirocin and chlorhexidine showers, and (4) a combination of nasal application of mupirocin and bathing in dilute bleach water. The "control" group as well as the three other arms will receive intensive hygiene education.

Decolonization with mupirocin ointment and chlorhexidine showers or dilute bleach baths in combination are likely to be more successful than either the application of nasal mupirocin ointment alone or hygiene measures alone. It is expected that these decolonization methods will result in a 50% relative reduction in MRSA colonization at 6 months.

Arms: arm 1: Intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group") arm 2: Application of mupirocin in the nasal mucosa alone arm 3: A combination of nasal application of mupirocin and chlorhexidine showers arm 4: A combination of nasal application of mupirocin and bathing in dilute bleach water
Interventions: intervention 1: Mupirocin ointment intervention 2: Chlorhexidine showers intervention 3: Bleach baths (dilute) intervention 4: Intensive education on personal hygiene
Intervention descriptions: intervention 1: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days. intervention 2: Apply Clorhexidine wash to entire body once daily for 5 days. intervention 3: Pour 2 ounces of bleach into water-filled bath tub. Soak in bath for 15 minutes. Apply once daily for 5 days. intervention 4: Repeat hygiene methods for 5 days.

Protocol documents: