US Guided Versus BlindI&D for Treatment of Soft Tissue Abscesses in the ED
Ultrasound Guided Versus Blind Incision and Drainage for the Treatment of Soft Tissue Abscesses in the Emergency Department
1 other identifier
interventional
124
1 country
1
Brief Summary
Standard treatment for a soft tissue abscess involves incision over the area of maximum fluctuance with drainage of purulence from the abscess cavity. The use of bedside ultrasound to guide this drainage has the potential to improve treatment outcomes by ensuring complete drainage of the cavity. Our hypothesis is that the use of ultrasound for guidance of incision and drainage of soft tissue abscesses will decrease treatment failure rate compared to standard blind incision and drainage. This hypothesis will be tested utilizing a blinded, randomized trial comparing standard incision and drainage to ultrasound guided incision and drainage.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2014
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
October 8, 2014
CompletedFirst Posted
Study publicly available on registry
October 15, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedApril 10, 2018
April 1, 2018
2.8 years
October 8, 2014
April 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Failure of Therapy
Patient with a reoccurrence of the abscess
7 days
Study Arms (2)
Ultrasound Guided
ACTIVE COMPARATORUltrasound Guided Incision and Drainage- Patients will undergo ultrasound guided drainage of the abscess using bedside ultrasound
Blind I&D
ACTIVE COMPARATORBlind Incision and Drainage- Patients will undergo drainage of the abscess using physical exam.
Interventions
Ultrasound guidance of the abscess drainage
Incision and drainage of abscess guided by physical exam alone
Eligibility Criteria
You may qualify if:
- Soft tissue abscess suspected by patient history and physical exam and confirmed by bedside ultrasound
- Able to provide written consent/ assent
- Incision and drainage to be performed by ED physician
You may not qualify if:
- Peritonsillar abscess
- Pilonidal cyst, genital or perirectal abscess
- Post-surgical wound infections
- Pregnant
- Prisoners
- Previous incision and drainage for current abscess
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UMASS Memorial Medical Center
Worcester, Massachusetts, 01655, United States
Related Publications (1)
Gaspari RJ, Sanseverino A, Gleeson T. Abscess Incision and Drainage With or Without Ultrasonography: A Randomized Controlled Trial. Ann Emerg Med. 2019 Jan;73(1):1-7. doi: 10.1016/j.annemergmed.2018.05.014. Epub 2018 Aug 17.
PMID: 30126754DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Romolo Gaspari, MD, PhD
UMass Memorial Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Executive Vice Chair, Department of Emergency Medicine
Study Record Dates
First Submitted
October 8, 2014
First Posted
October 15, 2014
Study Start
November 1, 2014
Primary Completion
August 30, 2017
Study Completion
December 1, 2017
Last Updated
April 10, 2018
Record last verified: 2018-04