Study of Wound Packing After Superficial Skin Abscess Drainage
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Abscess Skin Diseases, Infectious Boils Furuncle Carbuncle Folliculitis Cellulitis Wounds |
Procedure: Wound packing Procedure: NoPacking |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized Clinical Trial of Wound Packing Following Incision and Drainage of Superficial Skin Abscesses in the Pediatric Emergency Department |
- Healing (resolution, cosmesis, complications and recurrence) [ Time Frame: one month ] [ Designated as safety issue: Yes ]
- Ultrasound test characteristics [ Time Frame: day one ] [ Designated as safety issue: No ]
- Parental/patient satisfaction [ Time Frame: one month ] [ Designated as safety issue: No ]
- Cost-effectiveness [ Time Frame: one month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2008 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: NOPACKING
The comparison group will undergo a routine incision and drainage procedure but will not have packing placed inside the abscess cavity.
|
Procedure: 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.
|
|
Experimental: PACKING
This group will receive wound packing as per usual protocol
|
Procedure: Wound packing
1/4" non-iodoform packing loosely placed inside abscess cavity.
|
Eligibility| Ages Eligible for Study: | 1 Year to 24 Years |
| Genders Eligible for Study: | Both |
| Accepts 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)
Contacts and Locations More Information
No publications provided by New York University School of Medicine
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Michael Mojica, New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00746109 History of Changes |
| Other Study ID Numbers: | 08-143 |
| Study First Received: | September 2, 2008 |
| Last Updated: | January 3, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by New York University School of Medicine:
|
randomized clinical trial ultrasound prospective |
abscess packing incision and drainage superficial soft tissue infection |
Additional relevant MeSH terms:
|
Abscess Carbuncle Cellulitis Communicable Diseases Infection Folliculitis Skin Diseases Skin Diseases, Infectious Furunculosis Suppuration |
Inflammation Pathologic Processes Staphylococcal Skin Infections Staphylococcal Infections Gram-Positive Bacterial Infections Bacterial Infections Skin Diseases, Bacterial Connective Tissue Diseases Hair Diseases |
ClinicalTrials.gov processed this record on May 19, 2013