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Incision and Drainage Versus Needle Aspiration in Soft Tissue Abscesses

This study has been completed.
Sponsor:
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by:
University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01085929
First received: March 10, 2010
Last updated: March 11, 2010
Last verified: March 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Abscess
Cellulitis
 Procedure: Incision and Drainage
Procedure: Ultrasound Guided Aspiration
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ultrasound Guided Needle Drainage Versus Formal Incision and Drainage of Superficial Soft Tissue Abscesses in the Emergency Department Setting

Resource links provided by NLM:

MedlinePlus related topics: Cellulitis
U.S. FDA Resources

Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • Successful drainage of abscess [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    Clinical outcome at 7 days


Secondary Outcome Measures:
  • Successful drainage of abscess [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    Healing of abscess following drainage procedure at day 2

  • Ability to evacuate purulence from abscess [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    Amount of purulence produced by drainage procedure on day 1


Enrollment: 101
Study Start Date: August 2008
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01085929

Locations
United States, Massachusetts
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, United States, 02215
University of Massachusetts
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Romolo Gaspari, MD, PhD University of Massachusetts, Worcester
  More Information

No publications provided

Responsible Party: Romolo Gaspari, University of Massachusetts
ClinicalTrials.gov Identifier: NCT01085929     History of Changes
Other Study ID Numbers: UMass12522
Study First Received: March 10, 2010
Last Updated: March 11, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Massachusetts, Worcester:
abscess
infection
ultrasound guidance
incision and drainage
 needle aspiration
skin
ultrasound

Additional relevant MeSH terms:
Abscess
Cellulitis
Suppuration
Infection
 Inflammation
Pathologic Processes
Skin Diseases, Infectious
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 21, 2013