Study of Wound Packing After Superficial Skin Abscess Drainage
|ClinicalTrials.gov Identifier: NCT00746109|
Recruitment Status : Completed
First Posted : September 3, 2008
Last Update Posted : January 4, 2011
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 or disease||Intervention/treatment||Phase|
|Abscess Skin Diseases, Infectious Boils Furuncle Carbuncle Folliculitis Cellulitis Wounds||Procedure: Wound packing Procedure: NoPacking||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||March 2010|
Placebo Comparator: NOPACKING
The comparison group will undergo a routine incision and drainage procedure but will not have packing placed inside the abscess cavity.
This is a routine incision and drainage procedure but without the use of packing. Sterile gauze dressing will be placed over the abscess cavity.
This group will receive wound packing as per usual protocol
Procedure: Wound packing
1/4" non-iodoform packing loosely placed inside abscess cavity.
- Healing (resolution, cosmesis, complications and recurrence) [ Time Frame: one month ]
- Ultrasound test characteristics [ Time Frame: day one ]
- Parental/patient satisfaction [ Time Frame: one month ]
- Cost-effectiveness [ Time Frame: one month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00746109
|United States, New York|
|New York University / Bellevue Hospital Center|
|NY, New York, United States, 10016|