|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | New York University School of Medicine |
|---|---|
| Information provided by: | New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00746109 |
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 |
|---|---|
|
Abscess Skin Diseases, Infectious Boils Furuncle Carbuncle Folliculitis Cellulitis Wound |
Procedure: Wound packing Procedure: NoPacking |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Randomized Clinical Trial of Wound Packing Following Incision and Drainage of Superficial Skin Abscesses in the Pediatric Emergency Department |
| Study Start Date: | September 2008 |
| Arms | Assigned Interventions |
|---|---|
|
NOPACKING: Placebo Comparator
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.
|
|
PACKING: Experimental
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:
Exclusion Criteria:
Contacts and Locations| Contact: David O Kessler, MD | 212-562-3241 | dr.kessler@gmail.com |
| United States, New York | |
| New York University / Bellevue Hospital Center | Recruiting |
| NY, New York, United States, 10016 | |
| Principal Investigator: Michael Mojica, MD | |
More Information
| Responsible Party: | New York University School of Medicine ( Michael Mojica ) |
| Study ID Numbers: | 08-143 |
| Study First Received: | September 2, 2008 |
| Last Updated: | September 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00746109 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
randomized clinical trial ultrasound prospective |
abscess packing incision and drainage superficial soft tissue infection |
|
Hair Diseases Bacterial Infections Communicable Diseases Skin Diseases Carbuncle Furunculosis Staphylococcal Skin Infections Infection Inflammation Staphylococcal Infections |
Gram-Positive Bacterial Infections Cellulitis Skin Diseases, Infectious Pathologic Processes Skin Diseases, Bacterial Abscess Connective Tissue Diseases Suppuration Folliculitis |