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

Abscess Clinical Trial

Official title:

Comparison of Ultrasound-Guided Needle Aspiration and Open Incision and Drainage in the Management of Cutaneous Abscesses

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01186900
• Other study ID #: 2008198-01H
• Status: Terminated
• Phase: N/A
• First received: August 19, 2010
• Last updated: August 4, 2011
• Start date: June 2009
• Est. completion date: March 2011

Study information

• Verified date: August 2011
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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 department patients using concealed allocation in evaluating patient satisfaction.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abscess

Intervention

Procedure:
• ultrasound-guided needle aspiration
one time drainage at time of randomization

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction		7 days	No
Secondary	Failure rate		7 days	No