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Comparison of Ultrasound-Guided Needle Aspiration and Open Incision and Drainage for Cutaneous Abscesses

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ClinicalTrials.gov Identifier: NCT01186900
Recruitment Status : Terminated
First Posted : August 23, 2010
Last Update Posted : August 8, 2011
Sponsor:
Information provided by:
Ottawa Hospital Research Institute

Brief Summary:
The investigators propose to conduct a, two armed, randomized, controlled pilot study to assess the clinical effects of a) open incision, drainage with daily packing changes, compared to b) Ultrasound guided needle aspiration, in drainage of uncomplicated cutaneous abscesses below the skin surface of adult emergency department patients using concealed allocation in evaluating patient satisfaction.

Condition or disease Intervention/treatment Phase
Abscess Procedure: ultrasound-guided needle aspiration Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Ultrasound-Guided Needle Aspiration and Open Incision and Drainage in the Management of Cutaneous Abscesses
Study Start Date : June 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess Ultrasound
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ultrasound-guided needle aspiration
One arm is ultrasound-guided needle aspiration, the other active comparison is traditional open incision and drainage of skin abscess
Procedure: ultrasound-guided needle aspiration
one time drainage at time of randomization
Active Comparator: open incision and drainage Procedure: ultrasound-guided needle aspiration
one time drainage at time of randomization



Primary Outcome Measures :
  1. Patient satisfaction [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Failure rate [ Time Frame: 7 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients presenting to the Civic Campus emergency department of The Ottawa Hospital with an abscess less than 5 cm diameter, as judged by the attending emergency physician (measurement with tape measure for diameter) between the hours of 7 am and 10 pm will be approached for possible enrollment. Ultrasound will be used to assess the appropriate exclusion criteria.

Exclusion Criteria:

  • Patients under the age of 18 years,
  • Patients with a Glasgow coma scale score of <15 (i.e. not completely alert and oriented),
  • Patients suspected of having necrotising fascitis,
  • Patients with hemodynamic instability (defined as SBP <90, and/or HR >110),
  • Patients admitted to hospital,
  • Patients who are neither French nor English speaking,
  • Patients who are not available for telephone follow-up (i.e. homeless).
  • Ultrasound image demonstrates that the abscess is not compressible (generally indicates that the contents of the cyst includes solids, which would not be amenable to aspiration)
  • Ultrasound demonstrates that there is no abscess to manage,
  • Patients with perianal abscesses who have either Crohn's disease or ulcerative colitis or known perirectal fistula,
  • Patients with recurrent abscesses in the same location or abscesses present for more than 2 weeks
  • Patients with complex abscesses including deep tissue, sensitive body part involvement which includes: ears, eyes, lacrimal, orbital, submandibular, mouth, peritonsillar, and Bartholin's gland.
  • Patients with renal impairment, diabetes, immunocompromised (as these patients are at risk of becoming more ill if an abscess were able to grow).

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): NCT01186900


Locations
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y4E9
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Michael Woo, MD Ottawa Hospital Research Institute

Responsible Party: Dr. Jeffrey Perry, Department of Emergency Medicine, University of Ottawa
ClinicalTrials.gov Identifier: NCT01186900     History of Changes
Other Study ID Numbers: 2008198-01H
First Posted: August 23, 2010    Key Record Dates
Last Update Posted: August 8, 2011
Last Verified: August 2011

Keywords provided by Ottawa Hospital Research Institute:
skin abscess
needle aspiration
incision and drainage

Additional relevant MeSH terms:
Surgical Wound
Abscess
Wounds and Injuries
Suppuration
Infection
Inflammation
Pathologic Processes