- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01281930
Abscess Packing Versus Wick Placement After Incision and Drainage
June 15, 2018 updated by: Washington University School of Medicine
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
156
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
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- St. Louis Children's Hospital
-
-
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
6 months to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Wick placement into abscess cavity
|
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
|
Active Comparator: Full packing of abscess cavity
|
After incision and drainage plain 1/4-1/2 inch gauze packing material is placed into the cavity to fill it
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Abscess healing based upon clinical criteria and clinical judgement
Time Frame: 24-72 hours
|
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.
|
24-72 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain since abscess drainage
Time Frame: 24-72 hours
|
24-72 hours
|
Parent/guardian comfort with removing the packing material or wick from the abscess cavity
Time Frame: 24-72 hours
|
24-72 hours
|
Parent/guardian assessment of the abscess wound at 2 weeks
Time Frame: 2 weeks
|
2 weeks
|
Parent/guardian assessment of pus drainage at 2 weeks
Time Frame: 2 weeks
|
2 weeks
|
Need for further treatment of same abscess within 2 weeks
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
June 1, 2009
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
January 20, 2011
First Submitted That Met QC Criteria
January 20, 2011
First Posted (Estimate)
January 24, 2011
Study Record Updates
Last Update Posted (Actual)
June 19, 2018
Last Update Submitted That Met QC Criteria
June 15, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-0719 -201103241
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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