Clinical Trial Review
March 2013 | Volume 12 | Issue 3 | Features | 379 | Copyright © March 2013
Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform
the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To
participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.
SKIN AND SOFT TISSUE ABSCESS
Randomized Controlled Trial of Antibiotics in
the Management of Children With Community-
Acquired Skin and Soft Tissue Abscess
Undergoing Incision and Drainage
Sponsored by Ann & Robert H Lurie Children’s Hospital of Chicago,
the purpose of this study is to better understand why
children develop methicillin-resistant Staphylococcus aureus (MRSA) skin infections that require surgical drainage and
whether antibiotics are helpful after the infection is drained in
the operating room.
The emergence of community-acquired MRSA as a pervasive
cause of skin and soft tissue infections has increased the number
of children requiring incision and drainage (I&D) procedures
and heightened concerns about the optimal treatment strategy.
Data on patients with methicillin-sensitive Staphylococcus aureus (MSSA) abscesses, as well as emerging data on children with
minor MRSA skin and soft tissue abscesses suggest that I&D
alone is sufficient therapy. However, given concerns about the
pathogenicity of MRSA infections, many patients who require
hospital admission and I&D in the operating room receive postoperative
antibiotics. The primary objective of this randomized
controlled trial is to compare the effect of 5 days vs 1 day of postoperative
antibiotics on the rate of treatment failure following
I&D of abscesses in children in the era of pervasive MRSA infection.
Secondary outcomes to be measured include incidence of
additional skin and soft tissue infections in other body sites and
incidence of these infections in family members and household
contacts. Prospective data will be collected from wound cultures,
as well as from nasal, rectal, and skin cultures sent at the time of
initial I&D to assess for MRSA carrier status. Finally, survey data
will be used to assess epidemiologic risk factors.
Based on our preliminary susceptibility data, oral clindamycin
(10 mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic.
Patients allergic or intolerant to clindamycin will receive
oral trimethoprim-sulfamethoxazole [bactrim] (5 mg/kg trimethoprim
up to 160 mg, every 12 hours). The primary objective is
to measure clinical resolution of skin abscess at routine followup
visit 10 to 14 days postoperation. Secondary outcomes measured
include incidence of additional skin and soft tissue infections
in patients and in household contacts, as determined by
health care provider. Compliance to antibiotic regime will also
be assessed at this time (10-14 days postoperation, 3 months
postoperation, and 9 months postoperation.
Children aged between 1 month and 17 years who undergo I&D of
a skin and soft tissue abscess by a member of the Children’s Memorial
Hospital pediatric surgery faculty are eligible for inclusion
in this study. The following patients will be excluded from participation:
children who developed their infection while hospitalized
or within 2 weeks of unrelated hospital discharge; children with
surgical-site infections; children with inherent or acquired immunodeficiency,
including but not limited to transplant patients and
patients on chemotherapy or systemic corticosteroids; patients
admitted to the Infectious Disease (ID) service may be excluded
at the discretion of the ID attending; patients who are found to
have no discrete fluid collections at the time of attempted I&D; patients
allergic or intolerant to both bactrim and clindamycin; and
patients with cellulitis greater than 5 cm beyond the lateral margin
of the abscess (as determined by intraoperative measurements).
A Pilot Study Using Anakinra/Kineret for the
Treatment of Patients With Severe Atopic Dermatitis
Sponsored by the National Institute of Allergy and Infectious
Diseases, the purpose of this study is to assess the safety and
effectiveness of using anakinra to treat severe atopic dermatitis
in children. Severe refractory atopic dermatitis is a chronic inflammatory
pruritic skin condition that affects both children and
adults. The disease is marked by periods of exacerbation and
remission. Symptoms of atopic dermatitis may resolve by adolescence;
however, it is estimated that the disease may persist in
50% of affected children well into adulthood.
Current possible treatments of atopic dermatitis include the use
of topical corticosteroids, calcineurin inhibitors, phototherapy,
as well as systemic medications, eg, methotrexate, cyclosporine,
azathioprine, mycophenolate mofetil, and interferon-γ.
The difficulty with long-term treatment of this disease lies in its
chronic nature associated with severe episodes. The combination
of chronicity and severity of episodes of this diseases demands
more effective and better-tolerated therapeutic options
than those that are currently available. While the pathways of
allergic inflammation are different than those of other inflam-