Study of Wound Packing After Superficial Skin Abscess Drainage

Wounds Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746109
• Other study ID #: 08-143
• Status: Completed
• Phase: Phase 4
• First received: September 2, 2008
• Last updated: January 3, 2011
• Start date: September 2008
• Est. completion date: March 2010

Study information

• Verified date: January 2011
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 24 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abscess
• Boils
• Carbuncle
• Cellulitis
• Communicable Diseases
• Folliculitis
• Furuncle
• Infection
• Skin Diseases
• Skin Diseases, Infectious
• Wounds

Intervention

Procedure:
• Wound packing
1/4" non-iodoform packing loosely placed inside abscess cavity.
• 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.

Locations

Country	Name	City	State
United States	New York University / Bellevue Hospital Center	NY	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing (resolution, cosmesis, complications and recurrence)		one month	Yes
Primary	Ultrasound test characteristics		day one	No
Secondary	Parental/patient satisfaction		one month	No
Secondary	Cost-effectiveness		one month	No