Antibiotic Therapy After Incision and Drainage for Abscess
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00900510|
Recruitment Status : Withdrawn (Recruitment of this population in the hospital setting not practical.)
First Posted : May 12, 2009
Last Update Posted : November 6, 2017
Background: Skin abscesses are a growing problem in the general pediatric population around the world. While the standard treatment for an abscess/boil is incision and drainage, many physicians also prescribe antibiotics, despite the lack of evidence that antibiotics are necessary to help the wound heal. The purpose of this research study is to determine whether antibiotics are necessary after incision and drainage of a skin abscess in children. This is an important question because medical evidence has shown that using antibiotics when they are not needed has contributed to the increase of bacterial antibiotic resistance. In fact, several of the antibiotics that successfully killed Staph bacteria several years ago are now no longer effective because of antibiotic resistance. Now resistant forms of Staph bacteria, called "Community-Acquired Methicillin-Resistant Staph Aureus" (CA-MRSA), account for 50-85% of all pediatric skin abscesses. If antibiotics are not necessary then withholding them when appropriate may help slow the progression of antibiotic-resistant Staph infections.
Objective(s) and Hypothesis(es): The investigators believe that antibiotics are no better than placebo at achieving a cure after drainage of an abscess in a child. The objective of this study is to answer the question: Do antibiotics after abscess drainage result in a better chance of cure than placebo?
Potential Impact: If abscess drainage alone is shown to be as effective as drainage followed by antibiotics, then the routine use of antibiotics for this problem could be avoided. This would help limit the increasing antibiotic resistance of bacteria (especially CA-MRSA) in communities around the world. A well-designed study may provide the evidence to change the way children are treated for abscesses in a future where antibiotic resistant bacteria will be even more of a public health challenge.
|Condition or disease||Intervention/treatment||Phase|
|Abscess||Procedure: Incision and drainage Drug: Trimethoprim/Sulfamethoxazole (Bactrim) Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Use of Adjuvant Antibiotic Therapy After Incision and Drainage for Pediatric Abscess: A Prospective, Randomized, Double-blinded, Placebo-Controlled Trial|
|Study Start Date :||May 2009|
|Estimated Primary Completion Date :||May 2011|
|Estimated Study Completion Date :||May 2011|
Experimental: Drainage and placebo
Incision and drainage with placebo.
Procedure: Incision and drainage
Active Comparator: Drainage with TMP/SX
Drainage with Bactrim
Drug: Trimethoprim/Sulfamethoxazole (Bactrim)
- Resolution of abscess [ Time Frame: 5-7 days ]
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): NCT00900510
|United States, North Carolina|
|Wake Forest University School of Medicine|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Thomas Pranikoff, M.D.||Wake Forest University Health Sciences|