Incision and Drainage Versus Needle Aspiration in Soft Tissue Abscesses

NCT ID: NCT01085929

Last Updated: 2010-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Abscess Cellulitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Incision and Drainage

Abscess underwent incision and drainage

Group Type ACTIVE_COMPARATOR

Incision and Drainage

Intervention Type PROCEDURE

Surgical incision of the skin surface followed by expression of purulence with or without debridement or manual exploration of abscess cavity.

Ultrasound guided needle aspiration

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

Group Type ACTIVE_COMPARATOR

Ultrasound Guided Aspiration

Intervention Type PROCEDURE

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.

Interventions

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Incision and Drainage

Surgical incision of the skin surface followed by expression of purulence with or without debridement or manual exploration of abscess cavity.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beth Israel Deaconess Medical Center

OTHER

Sponsor Role collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role lead

Responsible Party

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University of Massachusetts

Principal Investigators

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Romolo Gaspari, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Worcester

Locations

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Beth Isreal Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

University of Massachusetts

Worcester, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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UMass12522

Identifier Type: -

Identifier Source: org_study_id

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