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

This study has been terminated.
Sponsor:
Information provided by:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01186900
First received: August 19, 2010
Last updated: August 4, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention
Abscess
 Procedure: ultrasound-guided needle aspiration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Ultrasound-Guided Needle Aspiration and Open Incision and Drainage in the Management of Cutaneous Abscesses

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Patient satisfaction [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Failure rate [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: August 19, 2010
Last Updated: August 4, 2011
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on June 18, 2013