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

This study is not yet open for participant recruitment.
Verified October 2012 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Amit Shah, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01698996
First received: October 1, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Blinded Trial of Abscess Management With Packing vs No Packing

Further study details as provided by 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]
  • Pain scores (daily pain scores for first week from patient diary) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Amount of Pain Medication Used [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Resources Utilized [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 476
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698996

Contacts
Contact: Amit Shah, MD amit.shah@me.com
Contact: Shelley McLeod shelley.mcleod@lhsc.on.ca

Locations
Canada, Ontario
London Health Sciences Centre Not yet recruiting
London, Ontario, Canada, N6A 5W9
Contact: Shelley McLeod         shelley.mcleod@lhsc.on.ca    
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Amit P Shah, MD London Health Sciences Centre
  More Information

No publications provided

Responsible Party: Amit Shah, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01698996     History of Changes
Other Study ID Numbers: 102928
Study First Received: October 1, 2012
Last Updated: October 1, 2012
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Abscess
Skin Diseases
Suppuration
 Infection
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013