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

March 30, 2015 updated by: Amit Shah, Lawson Health Research Institute
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: No Packing
Procedure: Packing vs No Packing
Experimental: Packing
Procedure: Packing vs No Packing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of complications (defined as a composite of the following: need for repeat incision and drainage by physician, need for admission to hospital, or need for escalation to intravenous antibiotics)
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of wounds "closed" at 1 week (wound size <0.5 cm length and depth and no drainage)
Time Frame: 7 days
7 days

Other Outcome Measures

Outcome Measure
Time Frame
Proportion of wounds "closed" at 2 weeks (wound size <0.5 cm length and depth and no drainage)
Time Frame: 14 days
14 days
Pain scores (daily pain scores for first week from patient diary)
Time Frame: 7 days
7 days
Amount of Pain Medication Used
Time Frame: 7 days
7 days
Resources Utilized
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Investigators

  • Principal Investigator: Amit P Shah, MD, London Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

October 1, 2012

First Submitted That Met QC Criteria

October 1, 2012

First Posted (Estimate)

October 3, 2012

Study Record Updates

Last Update Posted (Estimate)

March 31, 2015

Last Update Submitted That Met QC Criteria

March 30, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102928

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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