search
Back to results

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

Primary Purpose

Abscess

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
ultrasound-guided needle aspiration
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abscess focused on measuring skin abscess, needle aspiration, incision and drainage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • The Ottawa Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ultrasound-guided needle aspiration

open incision and drainage

Arm Description

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

Outcomes

Primary Outcome Measures

Patient satisfaction

Secondary Outcome Measures

Failure rate

Full Information

First Posted
August 19, 2010
Last Updated
August 4, 2011
Sponsor
Ottawa Hospital Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT01186900
Brief Title
Comparison of Ultrasound-Guided Needle Aspiration and Open Incision and Drainage for Cutaneous Abscesses
Official Title
Comparison of Ultrasound-Guided Needle Aspiration and Open Incision and Drainage in the Management of Cutaneous Abscesses
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Terminated
Study Start Date
June 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ottawa Hospital Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abscess
Keywords
skin abscess, needle aspiration, incision and drainage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound-guided needle aspiration
Arm Type
Experimental
Arm Description
One arm is ultrasound-guided needle aspiration, the other active comparison is traditional open incision and drainage of skin abscess
Arm Title
open incision and drainage
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
ultrasound-guided needle aspiration
Intervention Description
one time drainage at time of randomization
Primary Outcome Measure Information:
Title
Patient satisfaction
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Failure rate
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Woo, MD
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y4E9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs