Clinical trial NCT00746109: Study of Wound Packing After Superficial Skin Abscess Drainage
Official title: Randomized Clinical Trial of Wound Packing Following Incision and Drainage of Superficial Skin Abscesses in the Pediatric Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abscess
Skin Diseases, Infectious
Boils
Furuncle
Carbuncle
Folliculitis
Cellulitis
Wounds
Keywords: randomized
clinical trial
ultrasound
prospective
abscess
packing
incision and drainage
superficial soft tissue infection
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2008-09-03
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Healing (resolution, cosmesis, complications and recurrence)
timeFrame: one month
measure: Ultrasound test characteristics
timeFrame: day one
Secondary outcomes:
measure: Parental/patient satisfaction
timeFrame: one month
measure: Cost-effectiveness
timeFrame: one month
Other outcomes:
Locations:
city: NY
country: United States
facility: New York University / Bellevue Hospital Center
state: New York
Study officials:
References:
citation: Kessler DO, Krantz A, Mojica M. Randomized trial comparing wound packing to no wound packing following incision and drainage of superficial skin abscesses in the pediatric emergency department. Pediatr Emerg Care. 2012 Jun;28(6):514-7. doi: 10.1097/PEC.0b013e3182587b20.