Study of Wound Packing After Superficial Skin Abscess Drainage

Study Overview
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Brief Summary
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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.

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

Conditions
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Abscess, Skin Diseases, Infectious, Boils, Furuncle, Carbuncle, Folliculitis, Cellulitis, Wounds

Intervention / Treatment
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* Procedure: Wound packing
* Procedure: NoPacking


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: NOPACKING<br>The comparison group will undergo a routine incision and drainage procedure but will not have packing placed inside the abscess cavity. | Procedure: NoPacking<br>* This is a routine incision and drainage procedure but without the use of packing. Sterile gauze dressing will be placed over the abscess cavity.<br>|
| Experimental: PACKING<br>This group will receive wound packing as per usual protocol | Procedure: Wound packing<br>* 1/4 non-iodoform packing loosely placed inside abscess cavity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing (resolution, cosmesis, complications and recurrence) |  | one month | 
| Ultrasound test characteristics |  | day one | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental/patient satisfaction |  | one month | 
| Cost-effectiveness |  | one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized, clinical trial, ultrasound, prospective, abscess, packing, incision and drainage, superficial soft tissue infection