Evaluation of a Staphylococcus Eradication Protocol for Patients Who Present to the ED With Cutaneous Abscess

NCT01537783 | Completed Phase 4 Results

• 1 other identifier: ED Staph Eradication
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous Abscess

Keywords

abscess

Outcome Measures

Primary Outcomes (1)

• Recurrence of Cutaneous Abscess

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

  6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Drug: Chlorhexidine gluconate; Drug: Mupirocin

Standard of Care

NO INTERVENTION

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.

Interventions

Chlorhexidine gluconate DRUG

Scrubs applied once a day for 5 days

Also known as: Hibiclens

Intervention group

Mupirocin DRUG

Nasal mupirocin applied topically to both nostrils twice a day for 5 days

Also known as: Bactroban

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Abscess

Interventions

chlorhexidine gluconate; Mupirocin

Condition Hierarchy (Ancestors)

Suppuration; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epoxy Compounds; Ethers, Cyclic; Ethers; Organic Chemicals; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids

Limitations and Caveats

There were so many lost to follow-up patients in the intervention group that it is difficult to draw conclusions from this study.

Results Point of Contact

• Title: Scott Weiner, MD, MPH
• Organization: Brigham and Women's Hospital

sweiner@bwh.harvard.edu

617-732-5640

Study Officials

• Scott G Weiner, MD, MPH

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2012
• First Posted: February 23, 2012
• Study Start: September 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: April 13, 2017
• Results First Posted: March 13, 2017

Record last verified: 2017-03

Locations

US (1)