Abscess Packing Versus Wick Placement After Incision and Drainage
Primary Purpose
Superficial Abscess Packing
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Full packing into abscess cavity
Wick placement into abscess cavity
Sponsored by
About this trial
This is an interventional treatment trial for Superficial Abscess Packing focused on measuring Superficial abscess, packing material, wick, incision and drainage
Eligibility Criteria
Inclusion Criteria:
- Well appearing patient
- Abscesses restricted to the superficial areas of the extremities, buttocks, abdominal and thoracic walls, and back
- Patients presenting Saturday-Wednesday
Exclusion Criteria:
- Fever >38 degrees celsius
- Ill appearing patient
- Underlying immunodeficiency or disorder leading to chronic abscess formation
- Any reason for admission to hospital beyond the need for sedation at the time of follow-up
- Thursday-Friday
Sites / Locations
- St. Louis Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Wick placement into abscess cavity
Full packing of abscess cavity
Arm Description
Outcomes
Primary Outcome Measures
Abscess healing based upon clinical criteria and clinical judgement
Abscesses are assessed for pus accumulation, erythema from the wound, if the patient has a fever and the overall clinical judgment of the evaluating health care professional at the time of follow-up.
Secondary Outcome Measures
Pain since abscess drainage
Parent/guardian comfort with removing the packing material or wick from the abscess cavity
Parent/guardian assessment of the abscess wound at 2 weeks
Parent/guardian assessment of pus drainage at 2 weeks
Need for further treatment of same abscess within 2 weeks
Full Information
NCT ID
NCT01281930
First Posted
January 20, 2011
Last Updated
June 15, 2018
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01281930
Brief Title
Abscess Packing Versus Wick Placement After Incision and Drainage
Official Title
Abscess Packing Versus Wick Placement After Incision and Drainage
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
5. Study Description
Brief Summary
Abscesses or "boils" are becoming more common every year and are a common reason children come to the Emergency Department. For the abscess to heal the skin needs to be opened to let the pus come out. Often doctors put something called "packing material" or gauze into the abscess space to help aid in healing. It is not known if the type of "packing" that is done is necessary or if a more simple treatment is as good or better. With informed consent we randomly place a child into one (1) of two (2) groups in this study that will say if the child's abscess/boil is packed with gauze in the traditional way or if a wick (small piece) of gauze is placed after the abscess/boil is opened and the fluid is drained. After treatment in the emergency department the child will be scheduled to follow-up in the Pediatric Acute Wound Service (PAWS) clinic as all other children with this infection are scheduled. At this visit the healing of the wound will be checked by the staff in the clinic and will be scored. With this evaluation of the wound the hypothesis that for a simple superficial (skin) abscess/boil a gauze wick placement into the abscess/boil is as effective as placement of traditional gauze packing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Superficial Abscess Packing
Keywords
Superficial abscess, packing material, wick, incision and drainage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
156 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wick placement into abscess cavity
Arm Type
Experimental
Arm Title
Full packing of abscess cavity
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Full packing into abscess cavity
Intervention Description
After incision and drainage plain 1/4-1/2 inch gauze packing material is placed into the cavity to fill it
Intervention Type
Procedure
Intervention Name(s)
Wick placement into abscess cavity
Intervention Description
After incision and drainage of the abscess a piece of plain gauze 1/4-1 inch packing material that is as wide as can be easily passed through the opening is placed into the cavity spanning one diameter of the cavity
Primary Outcome Measure Information:
Title
Abscess healing based upon clinical criteria and clinical judgement
Description
Abscesses are assessed for pus accumulation, erythema from the wound, if the patient has a fever and the overall clinical judgment of the evaluating health care professional at the time of follow-up.
Time Frame
24-72 hours
Secondary Outcome Measure Information:
Title
Pain since abscess drainage
Time Frame
24-72 hours
Title
Parent/guardian comfort with removing the packing material or wick from the abscess cavity
Time Frame
24-72 hours
Title
Parent/guardian assessment of the abscess wound at 2 weeks
Time Frame
2 weeks
Title
Parent/guardian assessment of pus drainage at 2 weeks
Time Frame
2 weeks
Title
Need for further treatment of same abscess within 2 weeks
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Well appearing patient
Abscesses restricted to the superficial areas of the extremities, buttocks, abdominal and thoracic walls, and back
Patients presenting Saturday-Wednesday
Exclusion Criteria:
Fever >38 degrees celsius
Ill appearing patient
Underlying immunodeficiency or disorder leading to chronic abscess formation
Any reason for admission to hospital beyond the need for sedation at the time of follow-up
Thursday-Friday
Facility Information:
Facility Name
St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
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Abscess Packing Versus Wick Placement After Incision and Drainage
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