Abscess Packing Versus Wick Placement After Incision and Drainage

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Washington University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01281930
First received: January 20, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

Abscesses or "boils" are becoming more common every year and are a common reason children come to the Emergency Department. For the abscess to heal the skin needs to be opened to let the pus come out. Often doctors put something called "packing material" or gauze into the abscess space to help aid in healing. It is not known if the type of "packing" that is done is necessary or if a more simple treatment is as good or better. With informed consent we randomly place a child into one (1) of two (2) groups in this study that will say if the child's abscess/boil is packed with gauze in the traditional way or if a wick (small piece) of gauze is placed after the abscess/boil is opened and the fluid is drained. After treatment in the emergency department the child will be scheduled to follow-up in the Pediatric Acute Wound Service (PAWS) clinic as all other children with this infection are scheduled. At this visit the healing of the wound will be checked by the staff in the clinic and will be scored. With this evaluation of the wound the hypothesis that for a simple superficial (skin) abscess/boil a gauze wick placement into the abscess/boil is as effective as placement of traditional gauze packing.


Condition Intervention
Superficial Abscess Packing
Procedure: Full packing into abscess cavity
Procedure: Wick placement into abscess cavity

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Abscess Packing Versus Wick Placement After Incision and Drainage

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Abscess healing based upon clinical criteria and clinical judgement [ Time Frame: 24-72 hours ] [ Designated as safety issue: Yes ]
    Abscesses are assessed for pus accumulation, erythema from the wound, if the patient has a fever and the overall clinical judgment of the evaluating health care professional at the time of follow-up.


Secondary Outcome Measures:
  • Pain since abscess drainage [ Time Frame: 24-72 hours ] [ Designated as safety issue: No ]
  • Parent/guardian comfort with removing the packing material or wick from the abscess cavity [ Time Frame: 24-72 hours ] [ Designated as safety issue: No ]
  • Parent/guardian assessment of the abscess wound at 2 weeks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Parent/guardian assessment of pus drainage at 2 weeks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Need for further treatment of same abscess within 2 weeks [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: June 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Wick placement into abscess cavity Procedure: Wick placement into abscess cavity
After incision and drainage of the abscess a piece of plain gauze 1/4-1 inch packing material that is as wide as can be easily passed through the opening is placed into the cavity spanning one diameter of the cavity
Active Comparator: Full packing of abscess cavity Procedure: Full packing into abscess cavity
After incision and drainage plain 1/4-1/2 inch gauze packing material is placed into the cavity to fill it

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Well appearing patient
  • Abscesses restricted to the superficial areas of the extremities, buttocks, abdominal and thoracic walls, and back
  • Patients presenting Saturday-Wednesday

Exclusion Criteria:

  • Fever >38 degrees celsius
  • Ill appearing patient
  • Underlying immunodeficiency or disorder leading to chronic abscess formation
  • Any reason for admission to hospital beyond the need for sedation at the time of follow-up
  • Thursday-Friday
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01281930

Locations
United States, Missouri
St. Louis Children's Hospital Recruiting
St. Louis, Missouri, United States, 63110
Contact: Eric A Browner, M.D.    314-454-2341    browner_e@kids.wustl.edu   
Principal Investigator: Eric A Browner, M.D.         
Sponsors and Collaborators
Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Eric Browner M.D., Department of Pediatrics Divsion of Pediatric Emergency Medicine Washington University in St. Louis
ClinicalTrials.gov Identifier: NCT01281930     History of Changes
Other Study ID Numbers: 09-0719
Study First Received: January 20, 2011
Last Updated: January 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Superficial abscess
packing material
wick
incision and drainage

Additional relevant MeSH terms:
Abscess
Suppuration
Infection
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014