Is Loop Drainage of a Cutaneous Abscess in the Emergency Department as Effective as Incision and Drainage With Packing?
| Registry | NCT01897675, acronym LoopDrainage |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 233 (Actual) |
| Sponsor | Boston Medical Center (Other) |
| Conditions | Cutaneous Abscess |
| Interventions | Incision and Drainage with packing (wick) placement, Abscess drainage with loop placement (Procedure) |
| Dates | start 2013-08-01, primary completion 2017-03-01, completion 2017-03-09, first posted 2013-07-12, last updated 2018-04-06 |
| Locations | 1 site in United States |
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All trials for Cutaneous Abscess All trials of Incision and Drainage with packing (wick) placement All trials of Abscess drainage with loop placement
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Incision and Drainage with Packing | Active comparator | Procedure: 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 | Experimental | Procedure: 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 |
Sex: All, ages: 20 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Boston University Medical Center | Boston, Massachusetts | United States |