Abscesses, Furunculosis, Staphylococcus Aureus, Staphylococcal Skin Infections
Conditions
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.
Interventions
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.
GENETICChlorhexidine showers
Apply Clorhexidine wash to entire body once daily for 5 days.
PROCEDUREBleach baths (dilute)
Pour 2 ounces of bleach into water-filled bath tub. Soak in bath for 15 minutes. Apply once daily for 5 days.
BEHAVIORALIntensive education on personal hygiene
Repeat hygiene methods for 5 days.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* Any patient who presents with at least one serious skin or soft tissue infection requiring incision and drainage at an affiliated institution or clinic in the St. Louis metropolitan area
Exclusion criteria
* Patients with permanent indwelling catheters or percutaneous medical devices * Patients with a history of dialysis treatments, long term care facility admission, or presents with a surgical wound infection within the past year * Patients who are pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Eradicated of S. Aureus Carriage - 1 Month After Intervention | 1 month follow-up | Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient. Samples obtained by study team at follow-up visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection | 1, 4 and 6 month follow-ups | Recurrent Staphylococcus aureus Skin or Soft Tissue Infection is defined as incidence of skin abscess, impetigo, cellulitis, or spider bite in the 1 month following intervention. Infections reported by participant at follow-up visit. |
| Number of Participants Eradicated of S. Aureus Carriage - 4 Months After Intervention | 4 month follow-up | Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient. Samples obtained by study team at follow-up visit. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hygiene Education Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group) | 75 |
| Hygiene Education + Mupirocin Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days | 75 |
| Education + Mupirocin + Chlorhexidine Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days. | 75 |
| Education + Mupirocin + Bleach Baths Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes). | 75 |
| Total | 300 |
Baseline characteristics
| Characteristic | Hygiene Education | Hygiene Education + Mupirocin | Education + Mupirocin + Chlorhexidine | Education + Mupirocin + Bleach Baths | Total |
|---|---|---|---|---|---|
| Age, Continuous | 17.37 years STANDARD_DEVIATION 16.57 | 16.52 years STANDARD_DEVIATION 16.12 | 18.19 years STANDARD_DEVIATION 17.37 | 18.67 years STANDARD_DEVIATION 15.29 | 17.61 years STANDARD_DEVIATION 16.31 |
| Sex: Female, Male Female | 34 Participants | 37 Participants | 52 Participants | 38 Participants | 161 Participants |
| Sex: Female, Male Male | 41 Participants | 38 Participants | 23 Participants | 37 Participants | 139 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 72 | 1 / 72 | 5 / 70 | 11 / 68 |
| serious Total, serious adverse events | 0 / 72 | 0 / 72 | 0 / 70 | 0 / 68 |
Outcome results
Primary
Number of Participants Eradicated of S. Aureus Carriage - 1 Month After Intervention
Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient. Samples obtained by study team at follow-up visit.
Time frame: 1 month follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hygiene Education | Number of Participants Eradicated of S. Aureus Carriage - 1 Month After Intervention | 24 Participants |
| Hygiene Education + Mupirocin | Number of Participants Eradicated of S. Aureus Carriage - 1 Month After Intervention | 35 Participants |
| Education + Mupirocin + Chlorhexidine | Number of Participants Eradicated of S. Aureus Carriage - 1 Month After Intervention | 35 Participants |
| Education + Mupirocin + Bleach Baths | Number of Participants Eradicated of S. Aureus Carriage - 1 Month After Intervention | 34 Participants |
Secondary
Number of Participants Eradicated of S. Aureus Carriage - 4 Months After Intervention
Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient. Samples obtained by study team at follow-up visit.
Time frame: 4 month follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hygiene Education | Number of Participants Eradicated of S. Aureus Carriage - 4 Months After Intervention | 31 Participants |
| Hygiene Education + Mupirocin | Number of Participants Eradicated of S. Aureus Carriage - 4 Months After Intervention | 32 Participants |
| Education + Mupirocin + Chlorhexidine | Number of Participants Eradicated of S. Aureus Carriage - 4 Months After Intervention | 31 Participants |
| Education + Mupirocin + Bleach Baths | Number of Participants Eradicated of S. Aureus Carriage - 4 Months After Intervention | 36 Participants |
Secondary
Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection
Recurrent Staphylococcus aureus Skin or Soft Tissue Infection is defined as incidence of skin abscess, impetigo, cellulitis, or spider bite in the 1 month following intervention. Infections reported by participant at follow-up visit.
Time frame: 1, 4 and 6 month follow-ups
Population: Groups 1/4 have 1 more participant analyzed each than in participant flow module due to data collected by phone. They did not return to hospital for followup (colonization swabs were not obtained). Group 3 has 1 less participant analyzed than in participant flow module due to missing data point on followup survey. They were not able to be reached.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hygiene Education | Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection | 6 Month Follow-up | 28 Participants |
| Hygiene Education | Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection | 4 Month Follow-up | 26 Participants |
| Hygiene Education | Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection | 1 Month Follow-up | 17 Participants |
| Hygiene Education + Mupirocin | Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection | 6 Month Follow-up | 27 Participants |
| Hygiene Education + Mupirocin | Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection | 1 Month Follow-up | 14 Participants |
| Hygiene Education + Mupirocin | Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection | 4 Month Follow-up | 20 Participants |
| Education + Mupirocin + Chlorhexidine | Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection | 1 Month Follow-up | 7 Participants |
| Education + Mupirocin + Chlorhexidine | Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection | 6 Month Follow-up | 23 Participants |
| Education + Mupirocin + Chlorhexidine | Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection | 4 Month Follow-up | 19 Participants |
| Education + Mupirocin + Bleach Baths | Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection | 4 Month Follow-up | 18 Participants |
| Education + Mupirocin + Bleach Baths | Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection | 6 Month Follow-up | 21 Participants |
| Education + Mupirocin + Bleach Baths | Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection | 1 Month Follow-up | 12 Participants |