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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01085929
Other study ID # UMass12522
Secondary ID
Status Completed
Phase Phase 3
First received March 10, 2010
Last updated March 11, 2010
Start date August 2008
Est. completion date December 2009

Study information

Verified date March 2010
Source University of Massachusetts, Worcester
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 101
Est. completion date December 2009
Est. primary completion date November 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Beth Isreal Deaconess Medical Center Boston Massachusetts
United States University of Massachusetts Worcester Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
University of Massachusetts, Worcester Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Successful drainage of abscess Clinical outcome at 7 days 7 days Yes
Secondary Successful drainage of abscess Healing of abscess following drainage procedure at day 2 2 days Yes
Secondary Ability to evacuate purulence from abscess Amount of purulence produced by drainage procedure on day 1 Day 1 Yes
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