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Study of Wound Packing After Superficial Skin Abscess Drainage
This study is currently recruiting participants.
Study NCT00746109   Information provided by New York University School of Medicine
First Received: September 2, 2008   No Changes Posted

September 2, 2008
September 2, 2008
September 2008
 
  • Healing (resolution, cosmesis, complications and recurrence) [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Ultrasound test characteristics [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Parental/patient satisfaction [ Time Frame: one month ] [ Designated as safety issue: No ]
  • Cost-effectiveness [ Time Frame: one month ] [ Designated as safety issue: No ]
Same as current
 
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.

 
 
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
  • Abscess
  • Skin Diseases, Infectious
  • Boils
  • Furuncle
  • Carbuncle
  • Folliculitis
  • Cellulitis
  • Wound
  • Procedure: Wound packing
  • Procedure: NoPacking
  • Placebo Comparator: The comparison group will undergo a routine incision and drainage procedure but will not have packing placed inside the abscess cavity.
  • Experimental: This group will receive wound packing as per usual protocol
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
 
 
 

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)
Both
1 Year to 24 Years
No
Contact: David O Kessler, MD 212-562-3241 dr.kessler@gmail.com
United States
 
NCT00746109
Michael Mojica, New York University School of Medicine
08-143
New York University School of Medicine
 
 
New York University School of Medicine
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP