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
  Purpose

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 Intervention Phase
Abscess
Skin Diseases, Infectious
Boils
Furuncle
Carbuncle
Folliculitis
Cellulitis
Wounds
Procedure: Wound packing
Procedure: NoPacking
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Parental/patient satisfaction [ Time Frame: one month ] [ Designated as safety issue: No ]
  • Cost-effectiveness [ Time Frame: one month ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2008
Study Completion Date: March 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   1 Year to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00746109

Locations
United States, New York
New York University / Bellevue Hospital Center
NY, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
  More Information

No publications provided by New York University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Mojica, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00746109     History of Changes
Other Study ID Numbers: 08-143
Study First Received: September 2, 2008
Last Updated: January 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
randomized
clinical trial
ultrasound
prospective
abscess
packing
incision and drainage
superficial soft tissue infection

Additional relevant MeSH terms:
Abscess
Carbuncle
Cellulitis
Communicable Diseases
Infection
Folliculitis
Skin Diseases
Skin Diseases, Infectious
Furunculosis
Suppuration
Inflammation
Pathologic Processes
Staphylococcal Skin Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Skin Diseases, Bacterial
Connective Tissue Diseases
Hair Diseases

ClinicalTrials.gov processed this record on April 23, 2014