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
1 other identifier
interventional
101
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2008
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 10, 2010
CompletedFirst Posted
Study publicly available on registry
March 12, 2010
CompletedMarch 12, 2010
March 1, 2010
1.3 years
March 10, 2010
March 11, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Successful drainage of abscess
Clinical outcome at 7 days
7 days
Secondary Outcomes (2)
Successful drainage of abscess
2 days
Ability to evacuate purulence from abscess
Day 1
Study Arms (2)
Incision and Drainage
ACTIVE COMPARATORAbscess underwent incision and drainage
Ultrasound guided needle aspiration
ACTIVE COMPARATORUltrasound was used to identify the abscess location. A needle was introduced into the abscess cavity and aspiration of the contents were attempted.
Interventions
Surgical incision of the skin surface followed by expression of purulence with or without debridement or manual exploration of abscess cavity.
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 Criteria
You may qualify if:
- presenting to emergency department with skin abscess
- abscess required surgical drainage
- healthy appearing
You may not qualify if:
- pregnant
- unable to give consent
- abscess located in oral cavity
- abscess located on genitalia
- abscess located intra-gluteal at coccyx
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Massachusetts
Worcester, Massachusetts, 01655, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Romolo Gaspari, MD, PhD
University of Massachusetts, Worcester
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 10, 2010
First Posted
March 12, 2010
Study Start
August 1, 2008
Primary Completion
November 1, 2009
Study Completion
December 1, 2009
Last Updated
March 12, 2010
Record last verified: 2010-03