- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00746109
Study of Wound Packing After Superficial Skin Abscess Drainage
Randomized Clinical Trial of Wound Packing Following Incision and Drainage of Superficial Skin Abscesses in the Pediatric Emergency Department
Superficial skin and soft tissue abscess are frequently managed by opening them up with a procedure called "incision and drainage". It is routine practice in the United States to place packing material inside the abscess cavity after opening them up, in order to promote better wound healing and limit abscess recurrence. However, this practice has never been systematically studied or proven to decrease complications or improve healing. Patients with wound packing usually return to the emergency room or practice setting for multiple "wound checks" and dressing/packing changes which lead to missed days from work or school and utilization of healthcare resources. This procedure can often be painful and may even require conscious sedation (and the risks entailed) especially in children. With rates of superficial skin and soft tissue abscesses on the rise, and emergency room resources being stretched, it is important to determine whether packing wounds is necessary or even advantageous to patients.
This study is the first to systematically evaluate the efficacy of wound packing after superficial skin or soft tissue abscess incision and drainage in children. The investigators will be evaluating wound healing, complications, recurrence and pain associated with packing both short and long term. In addition, the investigators will also be evaluating the utility of bedside point-of-care ultrasound use in predicting the presence of pus inside the abscess cavity. This test may be useful to determine whether incision and drainage is necessary for an individual who has a skin infection that is suspicious for an abscess.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
New York
-
NY, New York, United States, 10016
- New York University / Bellevue Hospital Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 1 - 24 years (i.e. any child seen in PED)
- Suspected abscess deemed to need incision & drainage by attending physician or fellow
- Size of abscess is greater than or equal to 1cm
- Parent or patient consent, and child assent
Exclusion Criteria:
- Location of abscess on face, perianal, or genitals
- History of recurrent or chronic abscess
- Multiple abscesses requiring drainage at current visit
- Immunocompromised or unstable patient
- HIV, transplant recipient, immune deficiency syndrome
- immunosuppressive medications
- Wound already open/draining
- Previous participation in trial
- Patient will not be following up / managed by PES (e.g. surgical site)
Study Plan
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 |
---|---|
Placebo Comparator: NOPACKING
The comparison group will undergo a routine incision and drainage procedure but will not have packing placed inside the abscess cavity.
|
This is a routine incision and drainage procedure but without the use of packing.
Sterile gauze dressing will be placed over the abscess cavity.
|
Experimental: PACKING
This group will receive wound packing as per usual protocol
|
1/4" non-iodoform packing loosely placed inside abscess cavity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Healing (resolution, cosmesis, complications and recurrence)
Time Frame: one month
|
one month
|
Ultrasound test characteristics
Time Frame: day one
|
day one
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Parental/patient satisfaction
Time Frame: one month
|
one month
|
Cost-effectiveness
Time Frame: one month
|
one month
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Inflammation
- Disease Attributes
- Connective Tissue Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Staphylococcal Infections
- Suppuration
- Skin Diseases, Bacterial
- Hair Diseases
- Furunculosis
- Staphylococcal Skin Infections
- Infections
- Communicable Diseases
- Wounds and Injuries
- Abscess
- Cellulitis
- Skin Diseases, Infectious
- Skin Diseases
- Carbuncle
- Folliculitis
Other Study ID Numbers
- 08-143
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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