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Incision and Drainage Versus Needle Aspiration in Soft Tissue Abscesses

Primary Purpose

Abscess, Cellulitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Incision and Drainage
Ultrasound Guided Aspiration
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abscess focused on measuring abscess, infection, ultrasound guidance, incision and drainage, needle aspiration, skin, ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Isreal Deaconess Medical Center
  • University of Massachusetts

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Incision and Drainage

Ultrasound guided needle aspiration

Arm Description

Abscess underwent incision and drainage

Ultrasound was used to identify the abscess location. A needle was introduced into the abscess cavity and aspiration of the contents were attempted.

Outcomes

Primary Outcome Measures

Successful drainage of abscess
Clinical outcome at 7 days

Secondary Outcome Measures

Successful drainage of abscess
Healing of abscess following drainage procedure at day 2
Ability to evacuate purulence from abscess
Amount of purulence produced by drainage procedure on day 1

Full Information

First Posted
March 10, 2010
Last Updated
March 11, 2010
Sponsor
University of Massachusetts, Worcester
Collaborators
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01085929
Brief Title
Incision and Drainage Versus Needle Aspiration in Soft Tissue Abscesses
Official Title
Ultrasound Guided Needle Drainage Versus Formal Incision and Drainage of Superficial Soft Tissue Abscesses in the Emergency Department Setting
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abscess, Cellulitis
Keywords
abscess, infection, ultrasound guidance, incision and drainage, needle aspiration, skin, ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Incision and Drainage
Arm Type
Active Comparator
Arm Description
Abscess underwent incision and drainage
Arm Title
Ultrasound guided needle aspiration
Arm Type
Active Comparator
Arm Description
Ultrasound was used to identify the abscess location. A needle was introduced into the abscess cavity and aspiration of the contents were attempted.
Intervention Type
Procedure
Intervention Name(s)
Incision and Drainage
Intervention Description
Surgical incision of the skin surface followed by expression of purulence with or without debridement or manual exploration of abscess cavity.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound Guided Aspiration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Successful drainage of abscess
Description
Clinical outcome at 7 days
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Successful drainage of abscess
Description
Healing of abscess following drainage procedure at day 2
Time Frame
2 days
Title
Ability to evacuate purulence from abscess
Description
Amount of purulence produced by drainage procedure on day 1
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romolo Gaspari, MD, PhD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Isreal Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States

12. IPD Sharing Statement

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Incision and Drainage Versus Needle Aspiration in Soft Tissue Abscesses

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