A Comparison of Techniques for Treating Skin Abscesses
- Conditions
- Cutaneous Abscess
- Interventions
- Procedure: Incision and Drainage with packing (wick) placementProcedure: Abscess drainage with loop placement
- Registration Number
- NCT01897675
- Lead Sponsor
- Boston Medical Center
- Brief Summary
Management of abscesses traditionally involves incision and drainage (I\&D). Abscesses are frequently are "packed" or stented open with the presence of a wick, and traditional care requires re-visits every 2-3 days to have the packing removed and replaced, until finally the abscess cavity has closed, usually 1-2 weeks after initial presentation.
Recently there have been attempts to employ less invasive techniques for abscess management. One novel technique, "loop drainage", has been reported in case reports/case series for management of a variety of types of abscesses in the surgical subspecialty literature.
We propose to conduct a randomized prospective study comparing the efficacy of the loop drainage technique with the traditional incision and drainage technique of abscess management.
Patients presenting to the main or urgent care areas of the Emergency Department at Boston Medical Center for treatment of an abscess will be considered for enrollment as potential subjects. After the treating clinician identifies the patient as an appropriate subject, a Research Associate (RA) will approach the patient and obtain written informed consent to enroll in the study. The subject will then be randomized to the management arm of either loop drainage or traditional I\&D. The clinician will fill out a data sheet describing the abscess characteristics, and then perform either loop drainage or incision and drainage, depending on randomization and the subject will fill out a satisfaction survey. Fourteen days after initial visit, subjects will return for follow-up. The subject will fill out a satisfaction survey, and a study investigator blinded to the treatment group will assess the subject for abscess resolution, cosmetic outcome, number of follow-up visits, and complications.
The study investigators will then compare outcomes between the two study groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 233
- Adult patient over 18 years of age
- Presenting to the Boston Medical Center main Emergency Department or Urgent Care area for initial treatment of a skin abscess
- English speaking
- Able to provide written informed consent
- Willing to return in 14 days for follow-up visit
- Able to give a telephone number for follow-up contact
- Previously treated for this abscess
- Altered mental status
- Patients with active psychiatric issues that preclude their ability to provide informed consent
- Previously enrolled in the study
- Abscess is not amenable to treatment by an Emergency Physician in the Emergency Department
- Abscess is post-operative or post-procedure
- Clinician determines abscess is not amenable to drainage by particular method
- Abscess is too small for packing or loop
- Need for hospital admission
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Incision and Drainage with Packing Incision and Drainage with packing (wick) placement Abscess is cared for in the standard fashion, using an incision and drainage with packing (wick) placement. Packing to be changed every 2-3 days, at the discretion of the treating clinician, until abscess is considered resolved Loop Drainage Abscess drainage with loop placement Abscess is cared for using a minimally invasive abscess drainage with loop placement technique. Two (or more) stab incisions are made in the abscess, the cavity is probed and pus is drained, and a vessel loop is inserted and tied off. The patient manipulates the loop 3 times per day, and removes the loop when all redness is gone and no more pus is present
- Primary Outcome Measures
Name Time Method Abscess Resolution 14 days If no, which sign is present (check all that apply):
1. Fluctuance
2. Drainage
3. Induration
4. Warmth
5. Tenderness
6. Other __________
- Secondary Outcome Measures
Name Time Method Number of Complications 14 days need for new incision in the same abscess, extension of the original incision, starting antibiotics, changing antibiotics, admission
Patient Satisfaction Immediately After Procedure Time 0 How Satisfied is Patient Immediately after Procedure (likert scale) Did Patient Feel Discomfort During Procedure (likert scale)
Patient Satisfaction after Abscess Resolution 14 Days Patient Satisfaction with:
Number of Follow Up Visits (likert scale) Cosmetic Appearance (likert scale) Pain (likert scale) Overall abscess care (likert scaleNumber of Follow Up Visits 14 days Number of follow-up visits made to either Emergency Department or outpatient clinic for abscess care
Cosmetic Outcome 14 days Appearance according to wound scale
Wound Scale (presence or absence of)
1. Step-off of borders
2. Contour irregularities
3. Wound margin separation
4. Edge inversion
5. Excessive distortion
6. Overall appearance
Trial Locations
- Locations (1)
Boston University Medical Center
🇺🇸Boston, Massachusetts, United States