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Study of Wound Packing After Superficial Skin Abscess Drainage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00746109
Recruitment Status : Completed
First Posted : September 3, 2008
Last Update Posted : January 4, 2011
Information provided by:
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Abscess Skin Diseases, Infectious Boils Furuncle Carbuncle Folliculitis Cellulitis Wounds Procedure: Wound packing Procedure: NoPacking Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Wound Packing Following Incision and Drainage of Superficial Skin Abscesses in the Pediatric Emergency Department
Study Start Date : September 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

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.
Procedure: NoPacking
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
Procedure: Wound packing
1/4" non-iodoform packing loosely placed inside abscess cavity.

Primary Outcome Measures :
  1. Healing (resolution, cosmesis, complications and recurrence) [ Time Frame: one month ]
  2. Ultrasound test characteristics [ Time Frame: day one ]

Secondary Outcome Measures :
  1. Parental/patient satisfaction [ Time Frame: one month ]
  2. Cost-effectiveness [ Time Frame: one month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00746109

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United States, New York
New York University / Bellevue Hospital Center
NY, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Michael Mojica, New York University School of Medicine Identifier: NCT00746109    
Other Study ID Numbers: 08-143
First Posted: September 3, 2008    Key Record Dates
Last Update Posted: January 4, 2011
Last Verified: January 2011
Keywords provided by NYU Langone Health:
clinical trial
incision and drainage
superficial soft tissue infection
Additional relevant MeSH terms:
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Communicable Diseases
Skin Diseases, Infectious
Skin Diseases
Wounds and Injuries
Pathologic Processes
Connective Tissue Diseases
Hair Diseases
Staphylococcal Skin Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Skin Diseases, Bacterial