Study of Wound Packing After Superficial Skin Abscess Drainage
Primary Purpose
Abscess, Skin Diseases, Infectious, Boils
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Wound packing
NoPacking
Sponsored by
About this trial
This is an interventional treatment trial for Abscess focused on measuring randomized, clinical trial, ultrasound, prospective, abscess, packing, incision and drainage, superficial soft tissue infection
Eligibility Criteria
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)
Sites / Locations
- New York University / Bellevue Hospital Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
NOPACKING
PACKING
Arm Description
The comparison group will undergo a routine incision and drainage procedure but will not have packing placed inside the abscess cavity.
This group will receive wound packing as per usual protocol
Outcomes
Primary Outcome Measures
Healing (resolution, cosmesis, complications and recurrence)
Ultrasound test characteristics
Secondary Outcome Measures
Parental/patient satisfaction
Cost-effectiveness
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00746109
Brief Title
Study of Wound Packing After Superficial Skin Abscess Drainage
Official Title
Randomized Clinical Trial of Wound Packing Following Incision and Drainage of Superficial Skin Abscesses in the Pediatric Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
NYU Langone Health
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abscess, Skin Diseases, Infectious, Boils, Furuncle, Carbuncle, Folliculitis, Cellulitis, Wounds
Keywords
randomized, clinical trial, ultrasound, prospective, abscess, packing, incision and drainage, superficial soft tissue infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NOPACKING
Arm Type
Placebo Comparator
Arm Description
The comparison group will undergo a routine incision and drainage procedure but will not have packing placed inside the abscess cavity.
Arm Title
PACKING
Arm Type
Experimental
Arm Description
This group will receive wound packing as per usual protocol
Intervention Type
Procedure
Intervention Name(s)
Wound packing
Intervention Description
1/4" non-iodoform packing loosely placed inside abscess cavity.
Intervention Type
Procedure
Intervention Name(s)
NoPacking
Intervention Description
This is a routine incision and drainage procedure but without the use of packing. Sterile gauze dressing will be placed over the abscess cavity.
Primary Outcome Measure Information:
Title
Healing (resolution, cosmesis, complications and recurrence)
Time Frame
one month
Title
Ultrasound test characteristics
Time Frame
day one
Secondary Outcome Measure Information:
Title
Parental/patient satisfaction
Time Frame
one month
Title
Cost-effectiveness
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
New York University / Bellevue Hospital Center
City
NY
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22653459
Citation
Kessler DO, Krantz A, Mojica M. Randomized trial comparing wound packing to no wound packing following incision and drainage of superficial skin abscesses in the pediatric emergency department. Pediatr Emerg Care. 2012 Jun;28(6):514-7. doi: 10.1097/PEC.0b013e3182587b20.
Results Reference
derived
Learn more about this trial
Study of Wound Packing After Superficial Skin Abscess Drainage
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