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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

March 10, 2010
March 11, 2010
August 2008
November 2009   (final data collection date for primary outcome measure)
Successful drainage of abscess [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Clinical outcome at 7 days
Same as current
Complete list of historical versions of study NCT01085929 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Incision and Drainage Versus Needle Aspiration in Soft Tissue Abscesses
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Abscess
  • Cellulitis
  • 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.
  • 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.
  • Active Comparator: Incision and Drainage
    Abscess underwent incision and drainage
    Intervention: Procedure: Incision and Drainage
  • 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.
    Intervention: Procedure: Ultrasound Guided Aspiration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
December 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01085929
UMass12522
No
Romolo Gaspari, University of Massachusetts
University of Massachusetts, Worcester
Beth Israel Deaconess Medical Center
Principal Investigator: Romolo Gaspari, MD, PhD University of Massachusetts, Worcester
University of Massachusetts, Worcester
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP