A Comparison of Techniques for Treating Skin Abscesses

Study Overview
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Brief Summary
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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.

Official Title
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Is Loop Drainage of a Cutaneous Abscess in the Emergency Department as Effective as Incision and Drainage With Packing?

Conditions
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Cutaneous Abscess

Intervention / Treatment
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* Procedure: Incision and Drainage with packing (wick) placement
* Procedure: Abscess drainage with loop placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Incision and Drainage with Packing<br>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 | Procedure: Incision and Drainage with packing (wick) placement<br> <br> |
| Experimental: Loop Drainage<br>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 | Procedure: Abscess drainage with loop placement<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abscess Resolution | If no, which sign is present (check all that apply): Fluctuance Drainage Induration Warmth Tenderness Other __________ | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction Immediately After Procedure | How Satisfied is Patient Immediately after Procedure (likert scale) Did Patient Feel Discomfort During Procedure (likert scale) | Time 0 | 
| Cosmetic Outcome | Appearance according to wound scale Wound Scale (presence or absence of) Step-off of borders Contour irregularities Wound margin separation Edge inversion Excessive distortion Overall appearance | 14 days | 
| Patient Satisfaction after Abscess Resolution | Patient Satisfaction with: Number of Follow Up Visits (likert scale) Cosmetic Appearance (likert scale) Pain (likert scale) Overall abscess care (likert scale | 14 Days | 
| Number of Follow Up Visits | Number of follow-up visits made to either Emergency Department or outpatient clinic for abscess care | 14 days | 
| Number of Complications | need for new incision in the same abscess, extension of the original incision, starting antibiotics, changing antibiotics, admission | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cutaneous Abscess, Emergency Department