Evaluation of a Staphylococcus Eradication Protocol for Patients Who Present to the ED With Cutaneous Abscess
Primary Purpose
Cutaneous Abscess
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Chlorhexidine gluconate
Mupirocin
Sponsored by
About this trial
This is an interventional prevention trial for Cutaneous Abscess focused on measuring abscess
Eligibility Criteria
Inclusion Criteria:
- Adult patients aged 18 years of age or older who present to our emergency department with a skin abscess which has undergone incision and drainage in which pus was present, and for whom the attending emergency physician is planning on discharging the patient home.
Exclusion Criteria:
- Abscesses resulting from insect or animal bites or intravenous drug use (both of which can be polymicrobial), chronic wounds (>2 weeks), wounds where no drainage was obtained in the course of the I&D, reported allergy to chlorhexidine or mupirocin, lack of ability to follow-up the patient (lack of phone number or stable address). Additionally, patients will be excluded who are of high acuity (unstable vital signs), in distress, with an insurmountable language barrier, intoxication (or other cause of altered mental status), presenting with acute psychiatric illness, are victims of possible sexual assault, or prisoners.
Sites / Locations
- Tufts Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Standard of Care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Recurrence of Cutaneous Abscess
A patient's description that they have had another abscess since their index emergency department visit.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01537783
Brief Title
Evaluation of a Staphylococcus Eradication Protocol for Patients Who Present to the ED With Cutaneous Abscess
Official Title
A Randomized Trial to Evaluate a Staphylococcus Eradication Protocol for Patients Who Present to the Emergency Department With Cutaneous Abscess
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study, the investigators will enroll patients who present to the emergency department with abscesses to the study. The patients will be randomly selected to either have the standard of care, which includes the standard drainage of the abscess and then usually a follow-up visit to recheck the wound, or to have the standard of care plus instructions to use a topical scrub of a soap called chlorhexidine once a day for five days and twice daily application of a topical antibiotic ointment called mupirocin to the nasal passages for five days.
The investigators will then call back the patients at 7 days, 14 days (if in the treatment arm), 3 months and 6 months, to ask if they have had any recurrence of abscess formation. The study hypothesis is that the patients who have undergone the decontamination protocol will have fewer subsequent infections.
Detailed Description
Many people have heard of resistant "superbugs" which are causing worrisome infections in people around the world. One of these bacteria is called Methicillin Resistant Staphylococcus aureus (MRSA). Staph aureus is a pathogen that can lead to skin infections, but this newer strain is resistant to the standard antibiotic treatment that physicians used to render (usually penicillin-based). In addition, the community-acquired strain of MRSA is associated with creation of painful boils, or abscesses, which require patients to come and have a painful incision and drainage procedure in the ED. Soft tissue infections attributable to MRSA presenting to the ED and other ambulatory settings have increased at an alarming rate - from 32.1 to 48.1 visits per 1000 population when comparing data from the National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey from 1997 to 2005.
It is believed that MRSA is contracted from close contacts with other people who have the infection, and then it lives on the skin and nasal passages. For people who have recurrent skin infections, infectious disease experts sometimes recommend an "eradication" or "decolonization" protocol to try and kill off all of the MRSA. These protocols often involve a) a topical scrub to remove MRSA from the skin, b) a nasal antibiotic ointment to remove MRSA from the nasal passages, and occasionally c) an oral antibiotic. This procedure is usually recommended after seeing an infectious disease specialist, but to our knowledge, this has never been attempted from emergency department patients.
Therefore, in this study, the investigators will enroll patients who present to the emergency department with abscesses to the study. The patients will be randomly selected to either have the standard of care, which includes the standard drainage of the abscess and then usually a follow-up visit to recheck the wound, or to have the standard of care plus instructions to use a topical scrub of a soap called chlorhexidine once a day for five days and twice daily application of a topical antibiotic ointment called mupirocin to the nasal passages for five days.
The investigators will then call back the patients at 7 days, 14 days (if in the treatment arm), 3 months and 6 months, to ask if they have had any recurrence of abscess formation. The study hypothesis is that the patients who have undergone the decontamination protocol will have fewer subsequent infections.
Using a conservative estimate for the proportion of recurrence in the control group of 50%, a sample size of 50 (25 subjects in each group) will provide the investigators with 80% power to detect a statistically significant difference in the proportion of patients with recurrence between the treatment and control groups if the proportion of the treatment group with recurrent infection is 15%. If 60% of the control group experiences a recurrent infection, the study will have 80% power to detect a statistically significant difference if recurrence is observed in 23% of the treatment group.
If the hypothesis is true, it could greatly impact the care of patients who present with the ED with abscesses, and hopefully reduce the morbidity associated with having recurrent abscesses, including lost work and need to return for future painful incision and drainage procedures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Abscess
Keywords
abscess
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine gluconate
Other Intervention Name(s)
Hibiclens
Intervention Description
Scrubs applied once a day for 5 days
Intervention Type
Drug
Intervention Name(s)
Mupirocin
Other Intervention Name(s)
Bactroban
Intervention Description
Nasal mupirocin applied topically to both nostrils twice a day for 5 days
Primary Outcome Measure Information:
Title
Recurrence of Cutaneous Abscess
Description
A patient's description that they have had another abscess since their index emergency department visit.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients aged 18 years of age or older who present to our emergency department with a skin abscess which has undergone incision and drainage in which pus was present, and for whom the attending emergency physician is planning on discharging the patient home.
Exclusion Criteria:
Abscesses resulting from insect or animal bites or intravenous drug use (both of which can be polymicrobial), chronic wounds (>2 weeks), wounds where no drainage was obtained in the course of the I&D, reported allergy to chlorhexidine or mupirocin, lack of ability to follow-up the patient (lack of phone number or stable address). Additionally, patients will be excluded who are of high acuity (unstable vital signs), in distress, with an insurmountable language barrier, intoxication (or other cause of altered mental status), presenting with acute psychiatric illness, are victims of possible sexual assault, or prisoners.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott G Weiner, MD, MPH
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of a Staphylococcus Eradication Protocol for Patients Who Present to the ED With Cutaneous Abscess
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