Treatment of cutaneous abscess: A double-blind clinical study

Llera, Jorge L; Levy, Richard

doi:10.1016/s0196-0644(85)80727-7

Cited by 158 publications

(66 citation statements)

References 14 publications

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“…31,33,34 PEPs in our study were even more likely to pack wounds for adolescents and adults, yet tended to avoid procedural sedation for drainage procedures.…”

Section: Discussionmentioning

confidence: 70%

“…41 Prior to the escalation of CA-MRSA, incision and drainage alone was the preferred therapy for skin abscesses. 33 Presently, in the era of CA-MRSA, the literature regarding the effectiveness of adjuvant antibiotic therapy is conflicting, and recommendations from the CDC and the IDSA also differ. 2,4,10,16,31,42,43 Therefore, the need for rigorous trials is imperative; reduction of unnecessary and inappropriate antibiotic therapy could represent a major, beneficial paradigm shift in current practice.…”

Section: Discussionmentioning

confidence: 99%

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Emergency Management of Pediatric Skin and Soft Tissue Infections in the Community‐associated Methicillin‐resistant Staphylococcus aureus Era

Mistry

Weisz

Scott

2010

Academic Emergency Medicine

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Objectives: Skin and soft tissue infections (SSTIs) are increasing in incidence, yet there is no consensus regarding management of these infections in the era of community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA). This study sought to describe current pediatric emergency physician (PEP) management of commonly presenting skin infections.Methods: This was a cross-sectional survey of subscribers to the American Academy of Pediatrics Section on Emergency Medicine (AAP SoEM) list-serv. Enrollment occurred via the list-serv over a 3-month period. Vignettes of equivocal SSTI, cellulitis, and skin abscess were presented to participants, and knowledge, diagnostic, and therapeutic approaches were assessed.Results: In total, 366 of 606 (60.3%) list-serv members responded. The mean (± standard deviation [SD]) duration of practice was 13.6 (±7.9) years, and 88.6% practiced in a pediatric emergency department. Most respondents (72.7%) preferred clinical diagnosis alone for equivocal SSTI, as opposed to invasive or imaging modalities. For outpatient cellulitis, PEPs selected clindamycin (30.6%), trimethoprim-sulfa (27.0%), and first-generation cephalosporins (22.7%); methicillin-sensitive S. aureus (MSSA) was routinely covered, but many regimens failed to cover CA-MRSA (32.5%) or group A streptococcus (27.0%). For skin abscesses, spontaneous discharge (67.5%) was rated the most important factor in electing to perform a drainage procedure; fever (19.9%) and patient age (13.1%) were the lowest. PEPs elected to prescribe trimethoprim-sulfamethoxazole (TMP-Sx; 50.0%) or clindamycin (32.7%) after drainage; only 5% selected CA-MRSA-inactive agents. All PEPs suspected CA-MRSA as the etiology of skin abscesses, and many attributed sepsis (22.1%) and invasive pneumonia (20.5%) to CA-MRSA, as opposed to MSSA. However, 23.9% remained unaware of local CA-MRSA prevalence for even common infections.Conclusions: Practice variation exists among PEPs for management of SSTI. These results can be used to measure changes in SSTI practices as standardized approaches are delineated.

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“…31,33,34 PEPs in our study were even more likely to pack wounds for adolescents and adults, yet tended to avoid procedural sedation for drainage procedures.…”

Section: Discussionmentioning

confidence: 70%

Section: Discussionmentioning

confidence: 99%

Emergency Management of Pediatric Skin and Soft Tissue Infections in the Community‐associated Methicillin‐resistant Staphylococcus aureus Era

Mistry

Weisz

Scott

2010

Academic Emergency Medicine

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“…However, given the high cure rates in both the cephalexin and placebo arms-rates which are consistent with those of four recently published studies of SSTIs (88 to 96%) (1, 13, 27, 29)-it is doubtful that an active agent would have performed any better. The one previous placebo-controlled study of cephradine for soft tissue infections, including abscesses, was conducted in 1985 and included 50 subjects (17). That study found no difference in cure rates between the antibiotic and placebo groups; to our knowledge, microbiologic susceptibility was not reported.…”

Section: Discussionmentioning

confidence: 83%

Randomized, Double-Blind, Placebo-Controlled Trial of Cephalexin for Treatment of Uncomplicated Skin Abscesses in a Population at Risk for Community-Acquired Methicillin-Resistant Staphylococcus aureus Infection

Rajendran¹,

Young²,

Maurer³

et al. 2007

Antimicrob Agents Chemother

197

100

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Empirical use of beta-lactam antibiotics, the preferred agents for treating uncomplicated skin and soft tissue infections, may no longer be appropriate for these infections because of the increasing prevalence of community strains of methicillin-resistant Staphylococcus aureus (MRSA). Retrospective studies, however, suggest that outcomes are good even when beta-lactams are used. We conducted a randomized, double-blind trial of 166 outpatient subjects comparing placebo to cephalexin at 500 mg orally four times for 7 days after incision and drainage of skin and soft tissue abscesses. The primary outcome was clinical cure or failure 7 days after incision and drainage. S. aureus was isolated from 70.4% of abscess cultures. Of the isolates tested 87.8% were MRSA, 93% of which were positive for Panton-Valentine leucocidin genes. Clinical cure rates were 90.5% (95% confidence interval, 0.82 to 0.96) in the 84 placebo recipients and 84.1% (95% confidence interval, 0.74 to 0.91) in the 82 cephalexin recipients (difference in the two proportions, 0.0006; 95% confidence interval, ؊0.0461 to 0.0472; P ‫؍‬ 0.25). The 90.5% cure rate observed in the placebo arm and 84.1% cure rate observed in the cephalexin arm provide strong evidence that antibiotics may be unnecessary after surgical drainage of uncomplicated skin and soft tissue abscesses caused by community strains of MRSA.

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“…Publications of uSSTI studies were excluded for one of the following criteria: placebo add-on treatment, pediatric exclusivity, prevention or colonization trials, or inclusion of subjects with minor cutaneous abscesses treated via incision and drainage as surgical treatment. The latter group was excluded as any potential estimate of placebo effect could not be assessed independently of the surgical treatment effect (25)(26)(27).…”

Section: Methodsmentioning

confidence: 99%

Systematic Review and Meta-Analysis To Estimate Antibacterial Treatment Effect in Acute Bacterial Skin and Skin Structure Infection

Cates

Mitrani-Gold

et al. 2015

Antimicrob Agents Chemother

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A systematic literature review and meta-analysis were conducted to estimate the antibacterial treatment effect for linezolid and ceftaroline to inform on the design of acute bacterial skin and skin structure infection (ABSSSI) noninferiority trials. The primary endpoints included an early clinical treatment response (ECTR) defined as cessation of lesion spread at 48 to 72 h postrandomization and the test-of-cure (TOC) response defined as total resolution of the infection at 7 to 14 days posttreatment. The systematic review identified no placebo-controlled trials in ABSSSI, 4 placebo-controlled trials in uncomplicated skin and soft tissue infection as a proxy for placebo in ABSSSI, 12 linezolid trials in ABSSSI, 3 ceftaroline trials in ABSSSI, and 2 trials for nonantibacterial treatment. The ECTR rates at 48 to 72 h and corresponding 95% confidence intervals (CI) were 78.7% (95% CI, 61.1 to 96.3%) for linezolid, 74.0% (95% CI, 69.7 to 78.3%) for ceftaroline, and 59.0% (95% CI, 52.8 to 65.3%) for nonantibacterial treatment. The early clinical treatment effect could not be estimated, given no available placebo or proxy for placebo data for this endpoint. Clinical, methodological, and statistical heterogeneity influenced the selection of trials for the meta-analysis of the TOC treatment effect estimation. The pooled estimates of the TOC treatment response were 31.0% (95% CI, 6.2 to 55.9%) for the proxy for placebo, 88.1% (95% CI, 81.0 to 95.1%) for linezolid, and 86.1% (95% CI, 83.7 to 88.6%) for ceftaroline. The TOC clinical treatment effect estimation was 25.1% for linezolid and 27.8% for ceftaroline. The antibacterial treatment effect estimation at TOC will inform on the design and analysis of future noninferiority ABSSSI clinical trials. Over the past decade, robust clinical, scientific, and regulatory debate has emerged for initiatives to improve the design, execution, and analysis of antibacterial clinical trials (1-4). New trials for acute bacterial skin and skin structure infections (ABSSSI), previously referred to as complicated skin and skin structure infections (cSSTI), remain important, given the rise in incidence of methicillin-resistant Staphylococcus aureus infections and reports of treatment failure (5-8). Per guidance from the U.S. Food and Drug Administration (FDA), patient eligibility for enrollment in ABSSSI trials should be restricted to those with erysipelas, cellulitis, major cutaneous abscesses, and wound infections having a minimal lesion surface area involvement of 75 cm 2 (9). For trial endpoints, the traditional test-of-cure (TOC) endpoint, with the treatment success defined as total resolution of the infection at 7 to 14 days posttreatment, remains aligned with the European regulatory guidance, yet the treatment success for the primary efficacy endpoint aligned with the FDA guidance is defined as cessation of lesion spread after 48 to 72 h of treatment (9-11). Revisions to the enrollment and endpoint criteria in recent regulatory guidance for ABSSSI trials necessitate reevaluation of the...

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Treatment of cutaneous abscess: A double-blind clinical study

Cited by 158 publications

References 14 publications

Emergency Management of Pediatric Skin and Soft Tissue Infections in the Community‐associated Methicillin‐resistant Staphylococcus aureus Era

Emergency Management of Pediatric Skin and Soft Tissue Infections in the Community‐associated Methicillin‐resistant Staphylococcus aureus Era

Randomized, Double-Blind, Placebo-Controlled Trial of Cephalexin for Treatment of Uncomplicated Skin Abscesses in a Population at Risk for Community-Acquired Methicillin-Resistant Staphylococcus aureus Infection

Systematic Review and Meta-Analysis To Estimate Antibacterial Treatment Effect in Acute Bacterial Skin and Skin Structure Infection

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