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

NCT ID: NCT01186900

Last Updated: 2011-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Abscess

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ultrasound-guided needle aspiration

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

Group Type EXPERIMENTAL

ultrasound-guided needle aspiration

Intervention Type PROCEDURE

one time drainage at time of randomization

open incision and drainage

Group Type ACTIVE_COMPARATOR

ultrasound-guided needle aspiration

Intervention Type PROCEDURE

one time drainage at time of randomization

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ultrasound-guided needle aspiration

one time drainage at time of randomization

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Department of Emergency Medicine, University of Ottawa

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael Woo, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2008198-01H

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pilonidal Disease Wound Healing Study
NCT01857128 UNKNOWN PHASE4