Study of Wound Packing After Superficial Skin Abscess Drainage

This study has been completed.
Sponsor:
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00746109
First received: September 2, 2008
Last updated: January 3, 2011
Last verified: January 2011

September 2, 2008
January 3, 2011
September 2008
January 2010   (final data collection date for primary outcome measure)
  • Healing (resolution, cosmesis, complications and recurrence) [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Ultrasound test characteristics [ Time Frame: day one ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00746109 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Abscess
  • Skin Diseases, Infectious
  • Boils
  • Furuncle
  • Carbuncle
  • Folliculitis
  • Cellulitis
  • Wounds
  • Procedure: Wound packing
    1/4" non-iodoform packing loosely placed inside 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.
  • Placebo Comparator: NOPACKING
    The comparison group will undergo a routine incision and drainage procedure but will not have packing placed inside the abscess cavity.
    Intervention: Procedure: NoPacking
  • Experimental: PACKING
    This group will receive wound packing as per usual protocol
    Intervention: Procedure: Wound packing
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
March 2010
January 2010   (final data collection date for primary outcome measure)

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 information is only displayed when the study is recruiting subjects
United States
 
NCT00746109
08-143
Yes
Michael Mojica, New York University School of Medicine
New York University School of Medicine
Not Provided
Not Provided
New York University School of Medicine
January 2011

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