- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01186900
Comparison of Ultrasound-Guided Needle Aspiration and Open Incision and Drainage for Cutaneous Abscesses
August 4, 2011 updated by: Ottawa Hospital Research Institute
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1Y4E9
- The Ottawa Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / 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
|
one time drainage at time of randomization
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ACTIVE_COMPARATOR: open incision and drainage
|
one time drainage at time of randomization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient satisfaction
Time Frame: 7 days
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Failure rate
Time Frame: 7 days
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Michael Woo, MD, Ottawa Hospital Research Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (ACTUAL)
March 1, 2011
Study Completion (ACTUAL)
March 1, 2011
Study Registration Dates
First Submitted
August 19, 2010
First Submitted That Met QC Criteria
August 20, 2010
First Posted (ESTIMATE)
August 23, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
August 8, 2011
Last Update Submitted That Met QC Criteria
August 4, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008198-01H
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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