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OpenTrials
Completed

NCT Number: NCT01897675

A Comparison of Techniques for Treating Skin Abscesses

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Incision and Drainage with packing (wick) placement

Procedure

Abscess drainage with loop placement

Procedure

Primary outcomes

  1. Abscess Resolution

    Time frame: 14 days

    If no, which sign is present (check all that apply):

    • Fluctuance
    • Drainage
    • Induration
    • Warmth
    • Tenderness
    • Other __________

Secondary outcomes

  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)

    • Step-off of borders
    • Contour irregularities
    • Wound margin separation
    • Edge inversion
    • Excessive distortion
    • 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

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Registry information

Official study title

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

Acronym: LoopDrainage

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 12, 2013
Registry last updated
Apr 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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