Study of Wound Packing After Superficial Skin Abscess Drainage

January 3, 2011 updated by: NYU Langone Health

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • NY, New York, United States, 10016
        • New York University / Bellevue Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 24 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Healing (resolution, cosmesis, complications and recurrence)
Time Frame: one month
one month
Ultrasound test characteristics
Time Frame: day one
day one

Secondary Outcome Measures

Outcome Measure
Time Frame
Parental/patient satisfaction
Time Frame: one month
one month
Cost-effectiveness
Time Frame: one month
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

September 2, 2008

First Submitted That Met QC Criteria

September 2, 2008

First Posted (Estimate)

September 3, 2008

Study Record Updates

Last Update Posted (Estimate)

January 4, 2011

Last Update Submitted That Met QC Criteria

January 3, 2011

Last Verified

January 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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