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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01698996
First Posted: October 3, 2012
Last Update Posted: March 31, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amit Shah, Lawson Health Research Institute
  Purpose
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.

Condition Intervention
Uncomplicated Cutaneous Abscess Procedure: Packing vs No Packing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Blinded Trial of Abscess Management With Packing vs No Packing

Resource links provided by NLM:


Further study details as provided by Amit Shah, Lawson Health Research Institute:

Primary Outcome Measures:
  • 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 ]

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

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

Enrollment: 0
Study Start Date: March 2013
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: No Packing
No Packing
Procedure: Packing vs No Packing
Experimental: Packing
Packing
Procedure: Packing vs No Packing

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01698996


Locations
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Amit P Shah, MD London Health Sciences Centre
  More Information

Responsible Party: Amit Shah, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01698996     History of Changes
Other Study ID Numbers: 102928
First Submitted: October 1, 2012
First Posted: October 3, 2012
Last Update Posted: March 31, 2015
Last Verified: March 2015

Keywords provided by Amit Shah, Lawson Health Research Institute:
abscess
packing
emergency medicine
wound care
incision and drainage

Additional relevant MeSH terms:
Abscess
Suppuration
Infection
Inflammation
Pathologic Processes