Incision and Drainage Versus Needle Aspiration in Soft Tissue Abscesses

March 11, 2010 updated by: University of Massachusetts, Worcester

Ultrasound Guided Needle Drainage Versus Formal Incision and Drainage of Superficial Soft Tissue Abscesses in the Emergency Department Setting

The incidence of skin and soft tissue infections has increased dramatically over the last decade, in part due to increased prevalence of community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA). Incision and drainage (I&D) is considered the primary intervention, however some clinicians prefer ultrasound guided needle aspiration (US Asp). The investigators performed a randomized trial comparing US Asp to I&D for uncomplicated skin and soft tissue abscesses, with a subgroup analysis of patients with CA-MRSA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Isreal Deaconess Medical Center
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • presenting to emergency department with skin abscess
  • abscess required surgical drainage
  • healthy appearing

Exclusion Criteria:

  • pregnant
  • unable to give consent
  • abscess located in oral cavity
  • abscess located on genitalia
  • abscess located intra-gluteal at coccyx

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Incision and Drainage
Abscess underwent incision and drainage
Procedure: Incision and Drainage
Surgical incision of the skin surface followed by expression of purulence with or without debridement or manual exploration of abscess cavity.
ACTIVE_COMPARATOR: Ultrasound guided needle aspiration
Ultrasound was used to identify the abscess location. A needle was introduced into the abscess cavity and aspiration of the contents were attempted.
Procedure: Ultrasound Guided Aspiration
Ultrasound is used to identify the abscess cavity. An 18 gauge needle is introduced into the abscess cavity and manual aspiration of the abscess contents is attempted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful drainage of abscess
Time Frame: 7 days
Clinical outcome at 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful drainage of abscess
Time Frame: 2 days
Healing of abscess following drainage procedure at day 2
2 days
Ability to evacuate purulence from abscess
Time Frame: Day 1
Amount of purulence produced by drainage procedure on day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Collaborators

Beth Israel Deaconess Medical Center

Investigators

  • Principal Investigator: Romolo Gaspari, MD, PhD, University of Massachusetts, Worcester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ACTUAL)

November 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

March 10, 2010

First Submitted That Met QC Criteria

March 11, 2010

First Posted (ESTIMATE)

March 12, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 12, 2010

Last Update Submitted That Met QC Criteria

March 11, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMass12522

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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