Comparison of Ultrasound-Guided Needle Aspiration and Open Incision and Drainage for Cutaneous Abscesses
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 19, 2010
CompletedFirst Posted
Study publicly available on registry
August 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedAugust 8, 2011
August 1, 2011
1.7 years
August 19, 2010
August 4, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient satisfaction
7 days
Secondary Outcomes (1)
Failure rate
7 days
Study Arms (2)
Ultrasound-guided needle aspiration
EXPERIMENTALOne arm is ultrasound-guided needle aspiration, the other active comparison is traditional open incision and drainage of skin abscess
open incision and drainage
ACTIVE COMPARATORInterventions
one time drainage at time of randomization
Eligibility Criteria
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Ottawa Hospital
Ottawa, Ontario, K1Y4E9, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Woo, MD
Ottawa Hospital Research Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 19, 2010
First Posted
August 23, 2010
Study Start
June 1, 2009
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
August 8, 2011
Record last verified: 2011-08