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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

August 19, 2010
August 4, 2011
June 2009
March 2011   (final data collection date for primary outcome measure)
Patient satisfaction [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01186900 on ClinicalTrials.gov Archive Site
Failure rate [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Ultrasound-Guided Needle Aspiration and Open Incision and Drainage for Cutaneous Abscesses
Comparison of Ultrasound-Guided Needle Aspiration and Open Incision and Drainage in the Management of Cutaneous Abscesses

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Abscess
Procedure: ultrasound-guided needle aspiration
one time drainage at time of randomization
  • 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
    Intervention: Procedure: ultrasound-guided needle aspiration
  • Active Comparator: open incision and drainage
    Intervention: Procedure: ultrasound-guided needle aspiration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
March 2011
March 2011   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01186900
2008198-01H
No
Dr. Jeffrey Perry, Department of Emergency Medicine, University of Ottawa
Ottawa Hospital Research Institute
Not Provided
Principal Investigator: Michael Woo, MD Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP