Incision and Drainage Versus Needle Aspiration in Soft Tissue Abscesses

Cellulitis Clinical Trial

Official title:

Ultrasound Guided Needle Drainage Versus Formal Incision and Drainage of Superficial Soft Tissue Abscesses in the Emergency Department Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01085929
• Other study ID #: UMass12522
• 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

• Abscess
• Cellulitis

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