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Completed

NCT Number: NCT00746109

Study of Wound Packing After Superficial Skin Abscess Drainage

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.

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Key information

Conditions

Abscess Animal Diseases Bacterial Infections Bacterial Infections and Mycoses Boils Carbuncle Cellulitis Connective Tissue Diseases Fish Diseases Folliculitis Furuncle Furunculosis Gram-Positive Bacterial Infections Hair Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Staphylococcal Infections Staphylococcal Skin Infections Suppuration Surgical Wound Wounds Wounds and Injuries

Age range

1 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

New York University / Bellevue Hospital Center

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Wound packing

Procedure

1/4" non-iodoform packing loosely placed inside abscess cavity.

NoPacking

Procedure

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 outcomes

  1. Healing (resolution, cosmesis, complications and recurrence)

    Time frame: one month

  2. Ultrasound test characteristics

    Time frame: day one

Secondary outcomes

  1. Parental/patient satisfaction

    Time frame: one month

  2. Cost-effectiveness

    Time frame: one month

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Randomized Clinical Trial of Wound Packing Following Incision and Drainage of Superficial Skin Abscesses in the Pediatric Emergency Department

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 3, 2008
Registry last updated
Jan 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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