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

Not Applicable

Terminated

• Conditions: Abscess
• Interventions: Procedure: ultrasound-guided needle aspiration

• Registration Number: NCT01186900
• Lead Sponsor: Ottawa Hospital Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2010-08-19
• Study First Submitted QC: 2010-08-20
• Study First Posted: 2010-08-23
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-04
• Last Update Posted: 2011-08-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound-guided needle aspiration	ultrasound-guided needle aspiration	One arm is ultrasound-guided needle aspiration, the other active comparison is traditional open incision and drainage of skin abscess
open incision and drainage	ultrasound-guided needle aspiration	-

Primary Outcome Measures

Name	Time	Method
Patient satisfaction	7 days

Secondary Outcome Measures

Name	Time	Method
Failure rate	7 days

Trial Locations

Locations (1)

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada