AbscessNCT01186900
Comparison of Ultrasound-Guided Needle Aspiration and Open Incision and Drainage for Cutaneous Abscesses
A study testing ultrasound-guided needle aspiration in people with Abscess, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abscess
- What is being tested?
- ultrasound-guided needle aspiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2009to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Abscess
- Being tested
- ultrasound-guided needle aspiration
- Keywords
- skin abscess, needle aspiration, incision and drainage
- Medical subject headings
- Abscess, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided needle aspirationProcedure or surgery
one time drainage at time of randomization
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided needle aspiration | Experimental | One arm is ultrasound-guided needle aspiration, the other active comparison is traditional open incision and drainage of skin abscess Receives: Procedure: ultrasound-guided needle aspiration |
| open incision and drainage | Active comparator | Not described Receives: Procedure: ultrasound-guided needle aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Measured: 7 days
Secondary outcomes (1)
Failure rate
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startJun 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbscessStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- Michael Woo, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186900
- Sponsor's protocol ID
- 2008198-01H
- Status last verified
- Aug 2011
- First submitted
- 19 Aug 2010
- Last updated
- 8 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-Guided Needle Aspiration and Open Incision and Drainage in the Management of Cutaneous Abscesses
- ClinicalTrials.gov ID
- NCT01186900
- Acronym / sponsor ID
- 2008198-01H
- Conditions
- Abscess
- Keywords
- skin abscess, needle aspiration, incision and drainage
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 23 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided needle aspiration | Experimental | Procedure: ultrasound-guided needle aspirationOne arm is ultrasound-guided needle aspiration, the other active comparison is traditional open incision and drainage of skin abscess |
| open incision and drainage | Active comparator | Procedure: ultrasound-guided needle aspiration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (13 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound-guided needle aspirationone time drainage at time of randomization | Procedure or surgery | Ultrasound-guided needle aspiration, open incision and drainage |
Primary outcome
Patient satisfaction
Time frame: 7 days
1 secondary outcome
Failure rate
Time frame: 7 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Woo, MD principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound-guided needle aspiration in people with Abscess, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2011.