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A Comparison of Techniques for Treating Skin Abscesses (LoopDrainage)

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ClinicalTrials.gov Identifier: NCT01897675
Recruitment Status : Completed
First Posted : July 12, 2013
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Elissa Schechter-Perkins, 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.


Condition or disease Intervention/treatment Phase
Cutaneous Abscess Procedure: Incision and Drainage with packing (wick) placement Procedure: Abscess drainage with loop placement Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 233 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Is Loop Drainage of a Cutaneous Abscess in the Emergency Department as Effective as Incision and Drainage With Packing?
Actual Study Start Date : August 2013
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 9, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess

Arm Intervention/treatment
Active Comparator: Incision and Drainage with Packing
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
Experimental: Loop Drainage
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



Primary Outcome Measures :
  1. Abscess Resolution [ Time Frame: 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 :
  1. Patient Satisfaction Immediately After Procedure [ Time Frame: Time 0 ]
    How Satisfied is Patient Immediately after Procedure (likert scale) Did Patient Feel Discomfort During Procedure (likert scale)

  2. Cosmetic Outcome [ Time Frame: 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

  3. Patient Satisfaction after Abscess Resolution [ Time Frame: 14 Days ]

    Patient Satisfaction with:

    Number of Follow Up Visits (likert scale) Cosmetic Appearance (likert scale) Pain (likert scale) Overall abscess care (likert scale


  4. Number of Follow Up Visits [ Time Frame: 14 days ]
    Number of follow-up visits made to either Emergency Department or outpatient clinic for abscess care

  5. Number of Complications [ Time Frame: 14 days ]
    need for new incision in the same abscess, extension of the original incision, starting antibiotics, changing antibiotics, admission



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01897675


Locations
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Elissa Schechter-Perkins, MD, MPH Boston Medical Center

Additional Information:
Publications:
Responsible Party: Elissa Schechter-Perkins, Assistant Professor of Emergency Medicine, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01897675     History of Changes
Other Study ID Numbers: H-32294
First Posted: July 12, 2013    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elissa Schechter-Perkins, Boston Medical Center:
Cutaneous Abscess
Emergency Department

Additional relevant MeSH terms:
Abscess
Skin Diseases
Suppuration
Infection
Inflammation
Pathologic Processes