Trial Outcomes & Findings for Evaluation of a Staphylococcus Eradication Protocol for Patients Who Present to the ED With Cutaneous Abscess (NCT NCT01537783)

Results Overview

A patient's description that they have had another abscess since their index emergency department visit.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

6 months

Results posted on

2017-04-13

Participant milestones
Measure	Standard of Care Usual emergency department care	Intervention Usual emergency department care plus eradication protocol
Overall Study STARTED	25	25
Overall Study COMPLETED	14	23
Overall Study NOT COMPLETED	11	2

Reasons for withdrawal
Measure	Standard of Care Usual emergency department care	Intervention Usual emergency department care plus eradication protocol
Overall Study Lost to Follow-up	11	2

lost to followup

Baseline characteristics by cohort
Measure	Intervention Group n=25 Participants Standard emergency department care plus eradication protocol	Standard of Care n=25 Participants Standard emergency department care	Total n=50 Participants Total of all reporting groups
Age, Continuous	24.3 years STANDARD_DEVIATION 5.2 • n=14 Participants • lost to followup	35.4 years STANDARD_DEVIATION 11.4 • n=23 Participants • lost to followup	31.2 years STANDARD_DEVIATION 10.9 • n=37 Participants • lost to followup
Sex: Female, Male Female	9 Participants n=14 Participants • lost to followup	12 Participants n=23 Participants • lost to followup	21 Participants n=37 Participants • lost to followup
Sex: Female, Male Male	5 Participants n=14 Participants • lost to followup	11 Participants n=23 Participants • lost to followup	16 Participants n=37 Participants • lost to followup
Region of Enrollment United States	25 Participants n=25 Participants	25 Participants n=25 Participants	50 Participants n=50 Participants

Timeframe: 6 months

A patient's description that they have had another abscess since their index emergency department visit.

Outcome measures
Measure	Intervention Group n=14 Participants In this arm, patients are treated with chlorhexidine scrubs once a day for 5 days and mupirocin nasal ointment inserted to both nostrils twice a day for 5 days. Both treatments are begun 7 days after enrollment, or when the abscess has healed fully if it has not healed by day 7. Chlorhexidine gluconate: Scrubs applied once a day for 5 days Mupirocin: Nasal mupirocin applied topically to both nostrils twice a day for 5 days	Standard of Care n=23 Participants In this arm, patients receive routine care of their abscess, which may or may not include either topical or oral antibiotics, at the discretion of the treating clinician.
Recurrence of Cutaneous Abscess	5 Participants	7 Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Brigham and Women's Hospital

Phone: 617-732-5640