Abscess, Boils, Carbuncle, Cellulitis, Folliculitis, Furuncle, Skin Diseases, Infectious, Wounds
Conditions
Keywords
randomized, clinical trial, ultrasound, prospective, abscess, packing, incision and drainage, superficial soft tissue infection
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.
Interventions
PROCEDUREWound packing
1/4 non-iodoform packing loosely placed inside abscess cavity.
PROCEDURENoPacking
This is a routine incision and drainage procedure but without the use of packing. Sterile gauze dressing will be placed over the abscess cavity.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 24 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Healing (resolution, cosmesis, complications and recurrence) | one month |
| Ultrasound test characteristics | day one |
Secondary
| Measure | Time frame |
|---|---|
| Parental/patient satisfaction | one month |
| Cost-effectiveness | one month |
Countries
United States
Outcome results
None listed