A Randomized Blinded Trial of Abscess Management With Packing vs No Packing

NCT ID: NCT01698996

Last Updated: 2015-03-31

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Brief Summary

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Adult patients presenting to the emergency department with superficial cutaneous abscesses will be randomized after incision and drainage to standard care with wound packing or no packing to determine if there is a difference in the proportion of complications between the two groups.

Detailed Description

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Conditions

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Uncomplicated Cutaneous Abscess

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No Packing

No Packing

Group Type ACTIVE_COMPARATOR

Packing vs No Packing

Intervention Type PROCEDURE

Packing

Packing

Group Type EXPERIMENTAL

Packing vs No Packing

Intervention Type PROCEDURE

Interventions

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Packing vs No Packing

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ≥ 18 years
* Abscess ≤ 5cm in diameter
* Truncal or extremity location

Exclusion Criteria

* Post-operative abscess (abscess in location of operative incision, operation within the last 4 months)
* HIV/immunocompromised/transplant recipient/chronic oral steroid use
* Fever at triage (temp ≥38 degrees Celsius)
* Abscess secondary to Crohn's
* Multiple abscesses requiring drainage
* Prior participation in the study for the same abscess
* Incision and drainage performed with no packing required, or where abscess cavity is \<1 cm max diameter
* Bartholins/perigenital, perianal, or facial abscesses
* Complicated abscesses (fistula, suspicion of muscular extension, consultation/direct referral to general surgery)
* Inability to give consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Amit Shah

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amit P Shah, MD

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre

Locations

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London Health Sciences Centre

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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102928

Identifier Type: -

Identifier Source: org_study_id

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