Back to resultsA Randomized Blinded Trial of Abscess Management With Packing vs No Packing
Primary Purpose
Uncomplicated Cutaneous Abscess
Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Packing vs No Packing
Sponsored by
About this trial
This is an interventional treatment trial for Uncomplicated Cutaneous Abscess focused on measuring abscess, packing, emergency medicine, wound care, incision and drainage
Eligibility 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
Sites / Locations
- London Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
No Packing
Packing
Arm Description
No Packing
Packing
Outcomes
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)
Secondary Outcome Measures
Proportion of wounds "closed" at 1 week (wound size <0.5 cm length and depth and no drainage)
Full Information
NCT ID
NCT01698996
First Posted
October 1, 2012
Last Updated
March 30, 2015
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01698996
Brief Title
A Randomized Blinded Trial of Abscess Management With Packing vs No Packing
Official Title
A Randomized Blinded Trial of Abscess Management With Packing vs No Packing
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Withdrawn
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncomplicated Cutaneous Abscess
Keywords
abscess, packing, emergency medicine, wound care, incision and drainage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Packing
Arm Type
Active Comparator
Arm Description
No Packing
Arm Title
Packing
Arm Type
Experimental
Arm Description
Packing
Intervention Type
Procedure
Intervention Name(s)
Packing vs No Packing
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Proportion of wounds "closed" at 1 week (wound size <0.5 cm length and depth and no drainage)
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
Proportion of wounds "closed" at 2 weeks (wound size <0.5 cm length and depth and no drainage)
Time Frame
14 days
Title
Pain scores (daily pain scores for first week from patient diary)
Time Frame
7 days
Title
Amount of Pain Medication Used
Time Frame
7 days
Title
Resources Utilized
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit P Shah, MD
Organizational Affiliation
London Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Randomized Blinded Trial of Abscess Management With Packing vs No Packing
We'll reach out to this number within 24 hrs