Study of Wound Packing After Superficial Skin Abscess Drainage

Phase 4

Completed

• Conditions: Abscess; Skin Diseases, Infectious; Boils; Furuncle; Carbuncle; Folliculitis; Cellulitis; Wounds
• Interventions: Procedure: NoPacking; Procedure: Wound packing

• Registration Number: NCT00746109
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-02
• Study First Submitted QC: 2008-09-02
• Study First Posted: 2008-09-03
• Primary Completion: 2010-01
• Study Completion: 2010-03
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-03
• Last Update Posted: 2011-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NOPACKING	NoPacking	The comparison group will undergo a routine incision and drainage procedure but will not have packing placed inside the abscess cavity.
PACKING	Wound packing	This group will receive wound packing as per usual protocol

Primary Outcome Measures

Name	Time	Method
Healing (resolution, cosmesis, complications and recurrence)	one month
Ultrasound test characteristics	day one

Secondary Outcome Measures

Name	Time	Method
Parental/patient satisfaction	one month
Cost-effectiveness	one month

Trial Locations

Locations (1)

New York University / Bellevue Hospital Center; 🇺🇸 NY, New York, United States